<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02237508</url>
  </required_header>
  <id_info>
    <org_study_id>Z7200J02</org_study_id>
    <secondary_id>2014-002081-69</secondary_id>
    <nct_id>NCT02237508</nct_id>
  </id_info>
  <brief_title>A Clinical Study to Evaluate Z7200 (Budesonide/Formoterol) Pharmacokinetics Profile in Healthy Volunteers</brief_title>
  <official_title>An Open-Label, Single-dose, Randomized, Five-Period Cross-over to Compare Pharmacokinetics Profiles of Z7200 and Symbicort Turbohaler, With and Without Charcoal Blockade in Healthy Volunteers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zambon SpA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zambon SpA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective was:&#xD;
&#xD;
      - to assess the bioequivalence of a single dose (two inhalations) of the test product&#xD;
      compared to the reference product, with and without charcoal blockade.&#xD;
&#xD;
      The secondary objectives were:&#xD;
&#xD;
        -  to assess the pharmacokinetic profile of budesonide and formoterol in plasma after a&#xD;
           single dose (two inhalations) of the test product and the reference product, with and&#xD;
           without charcoal blockade.&#xD;
&#xD;
        -  to assess the safety and tolerability of the test product and the reference product,&#xD;
           with and without charcoal blockade.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a single center, open label, randomized, five-period crossover, single-dose study in&#xD;
      healthy volunteers aged 18 to 45 years. A total of 90 volunteers were enrolled, with 9&#xD;
      subjects in each of the 10 treatment sequences.&#xD;
&#xD;
      The study consisted of 5 treatment periods, each lasting approximately 48h, separated by a&#xD;
      washout period of a minimum of 5 days. RS01 and/or Symbicort Turbohaler device use training&#xD;
      was provided on Day -1 and Day 1 of each treatment period. Subjects were screened for&#xD;
      eligibility to participate in the study -28 to -2 days prior to the first treatment period,&#xD;
      and were randomized to one of 10 treatment sequencies containing the following 5 treatment&#xD;
      arms on Day 1 of the first treatment period:&#xD;
&#xD;
      Treatment A: Z7200 without oral activated charcoal* Treatment B1: Symbicort 1 without oral&#xD;
      activated charcoal* Treatment B2: Symbicort 2 without oral activated charcoal* Treatment C:&#xD;
      Z7200 with oral activated charcoal** Treatment D: Symbicort with oral activated charcoal**&#xD;
&#xD;
      Subjects were admitted to the clinical unit at 8.00 on the morning of Day -1, and were dosed&#xD;
      on the morning of Day 1 following an overnight fast (minimum of 8h). On Day 2, following&#xD;
      collection of the 24-h PK blood sample, subjects were discharged.&#xD;
&#xD;
      * Subjects who received treatments A, B1 and B2 rinsed their mouth vigorously with 50 mL&#xD;
      water for 3 to 5 sec immediately after the second inhalation.&#xD;
&#xD;
      ** A charcoal blockade was used to prevent absorption from oropharyngeal and GI tract, in&#xD;
      order to assess the pulmonary deposition of budesonide and formoterol, with periods performed&#xD;
      without a charcoal blockade allowing the assessment of the total systemic exposure to the&#xD;
      drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC0-t of Budesonide With and Without Charcoal Blockade</measure>
    <time_frame>0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)</time_frame>
    <description>Area under the plasma concentration-time curve from time zero to the last detectable level calculations were performed using the linear trapezoidal rule.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-t of Formoterol With and Without Charcoal Blockade</measure>
    <time_frame>0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)</time_frame>
    <description>Area under the plasma concentration-time curve from time zero to the last detectable level calculations were performed using the linear trapezoidal rule.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Budesonide With and Without Charcoal Blockade</measure>
    <time_frame>0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)</time_frame>
    <description>Maximum plasma level of budesonide with and without charcoal blockade. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Formoterol With and Without Charcoal Blockade</measure>
    <time_frame>0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)</time_frame>
    <description>Maximum plasma level of formoterol with and without charcoal blockade. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC0-30 of Budesonide With and Without Charcoal Blockade.</measure>
    <time_frame>0-30 min (0, 2, 5, 10, 15, 20, and 30 min)</time_frame>
    <description>Area under the plasma concentration-time curve from time zero to 30 minutes calculations were performed using the linear trapezoidal rule.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-30 of Formoterol With and Without Charcoal Blockade.</measure>
    <time_frame>0-30 min (0, 2, 5, 10, 15, 20, and 30 min)</time_frame>
    <description>Area under the plasma concentration-time curve from time zero to 30 minutes calculations were performed using the linear trapezoidal rule.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-∞ of Budesonide With and Without Charcoal Blockade</measure>
    <time_frame>0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)</time_frame>
    <description>Area under the plasma concentration-time curve from time zero to infinity calculations were performed using the linear trapezoidal rule.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-∞ of Formoterol With and Without Charcoal Blockade</measure>
    <time_frame>0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)</time_frame>
    <description>Area under the plasma concentration-time curve from time zero to infinity calculations were performed using the linear trapezoidal rule.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax for Budesonide With and Without Charcoal Blockade</measure>
    <time_frame>0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)</time_frame>
    <description>Time at which the maximum plasma level (Cmax) occurred with and without charcoal blockade.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax for Formoterol With and Without Charcoal Blockade</measure>
    <time_frame>0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)</time_frame>
    <description>Time at which the maximum plasma level (Cmax) occurred with and without charcoal blockade.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 for Budesonide With and Without Charcoal Blockade</measure>
    <time_frame>0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)</time_frame>
    <description>Apparent elimination half-life calculated as 0.693/lambda zeta, with and without charcoal blockade.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 for Formoterol With and Without Charcoal Blockade</measure>
    <time_frame>0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)</time_frame>
    <description>Apparent elimination half-life calculated as 0.693/lambda zeta, with and without charcoal blockade.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)</measure>
    <time_frame>At 75 min (1.25 hours) post-dose</time_frame>
    <description>FEV1 refers to the volume of air that an individual can exhale during a forced breath in 1 second.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.&#xD;
and Symbicort 2, together. Please note that, within the safety population, 90 subjects received Treatment B. This would mean that theorically 180 participants received Symbicort 1 and Symbicort 2, together.&#xD;
But some subjects were excluded from the statistical analysis for various reasons so that the total number included in the statistical anlysis for treatment B is 174.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Ratio of Forced Expiratory Volume in 1 Second to Forced Vital Capacity (FEV1/FVC)</measure>
    <time_frame>At 75 min (1.25 hours) post-dose</time_frame>
    <description>FVC = Forced vital capacity. It is the full amount of air that can be exhaled with effort in a complete breath.&#xD;
FEV1/FVC = Tiffenau-Pinelli Index. This parameter represents the measurement of the amount of air an individual can forcefully exhale from his/her lungs.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.&#xD;
Please note that, within the safety population, 90 subjects received Treatment B. This would mean that theorically 180 participants received Symbicort 1 and Symbicort 2, together.&#xD;
But 6 subjects were excluded from the statistical analysis for various reasons so that the total number included in the statistical anlysis for treatment B is 174.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Peak Expiratory Flow Rate (PEFR)</measure>
    <time_frame>At 75 min (1.25 hours) post-dose</time_frame>
    <description>PEFR is the highest rate at which gases can be expelled from the lungs via an open mouth. Its measurement is a simple procedure in which an individual takes a full inspiration and blows out as forcibly as possible into an instrument called a peak flow meter, which measures the maximal gas flow in an exhalation in liters per minute.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.Please note that, within the safety population, 90 subjects received Treatment B. This would mean that theorically 180 participants received Symbicort 1 and Symbicort 2, together. But 6 subjects were excluded from the statistical analysis for various reasons so that the total number included in the statistical anlysis for treatment B is 174.</description>
  </secondary_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>A-B1-B2-C-D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B2: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period of a minimum of 5 days followed treatment periods 1 to 4.&#xD;
Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B1-C-A-D-B2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B2: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period of a minimum of 5 day followed treatment periods 1 to 4.&#xD;
Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C-D-B1-B2-A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B2: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period of a minimum of 5 day followed treatment periods 1 to 4.&#xD;
Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D-B2-C-A-B1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B2: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period of a minimum of 5 day followed treatment periods 1 to 4.&#xD;
Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B2-A-D-B1-C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B2: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period of a minimum of 5 day followed treatment periods 1 to 4.&#xD;
Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D-C-B2-B1-A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B2: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period of a minimum of 5 day followed treatment periods 1 to 4.&#xD;
Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B2-D-A-C-B1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B2: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period of a minimum of 5 day followed treatment periods 1 to 4.&#xD;
Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A-B2-B1-D-C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B2: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period of a minimum of 5 day followed treatment periods 1 to 4.&#xD;
Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B1-A-C-B2-D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B2: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period of a minimum of 5 day followed treatment periods 1 to 4.&#xD;
Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C-B1-D-A-B2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B2: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period of a minimum of 5 day followed treatment periods 1 to 4.&#xD;
Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Z7200 without oral activated charcoal</intervention_name>
    <description>160 ug budesonide and 4.5 ug formoterol fumarate dihydrate, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).</description>
    <arm_group_label>A-B1-B2-C-D</arm_group_label>
    <arm_group_label>A-B2-B1-D-C</arm_group_label>
    <arm_group_label>B1-A-C-B2-D</arm_group_label>
    <arm_group_label>B1-C-A-D-B2</arm_group_label>
    <arm_group_label>B2-A-D-B1-C</arm_group_label>
    <arm_group_label>B2-D-A-C-B1</arm_group_label>
    <arm_group_label>C-B1-D-A-B2</arm_group_label>
    <arm_group_label>C-D-B1-B2-A</arm_group_label>
    <arm_group_label>D-B2-C-A-B1</arm_group_label>
    <arm_group_label>D-C-B2-B1-A</arm_group_label>
    <other_name>budesonide/formoterol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Symbicort Turbohaler without oral activated charcoal</intervention_name>
    <description>320 ug budesonide and 9 ug formoterol fumarate dihydrate, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).</description>
    <arm_group_label>A-B1-B2-C-D</arm_group_label>
    <arm_group_label>A-B2-B1-D-C</arm_group_label>
    <arm_group_label>B1-A-C-B2-D</arm_group_label>
    <arm_group_label>B1-C-A-D-B2</arm_group_label>
    <arm_group_label>B2-A-D-B1-C</arm_group_label>
    <arm_group_label>B2-D-A-C-B1</arm_group_label>
    <arm_group_label>C-B1-D-A-B2</arm_group_label>
    <arm_group_label>C-D-B1-B2-A</arm_group_label>
    <arm_group_label>D-B2-C-A-B1</arm_group_label>
    <arm_group_label>D-C-B2-B1-A</arm_group_label>
    <other_name>budesonide/formoterol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Z7200 with oral activated charcoal</intervention_name>
    <description>160 ug budesonide and 4.5 ug formoterol fumarate dihydrate, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).</description>
    <arm_group_label>A-B1-B2-C-D</arm_group_label>
    <arm_group_label>A-B2-B1-D-C</arm_group_label>
    <arm_group_label>B1-A-C-B2-D</arm_group_label>
    <arm_group_label>B1-C-A-D-B2</arm_group_label>
    <arm_group_label>B2-A-D-B1-C</arm_group_label>
    <arm_group_label>B2-D-A-C-B1</arm_group_label>
    <arm_group_label>C-B1-D-A-B2</arm_group_label>
    <arm_group_label>C-D-B1-B2-A</arm_group_label>
    <arm_group_label>D-B2-C-A-B1</arm_group_label>
    <arm_group_label>D-C-B2-B1-A</arm_group_label>
    <other_name>budesonide/formoterol with coadministration of charcoal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Symbicort Turbohaler with oral activated charcoal</intervention_name>
    <description>320 ug budesonide and 9 ug formoterol fumarate dihydrate, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation from a Symbicort Turbohaler, with charcoal blockade (Treatment D).</description>
    <arm_group_label>A-B1-B2-C-D</arm_group_label>
    <arm_group_label>A-B2-B1-D-C</arm_group_label>
    <arm_group_label>B1-A-C-B2-D</arm_group_label>
    <arm_group_label>B1-C-A-D-B2</arm_group_label>
    <arm_group_label>B2-A-D-B1-C</arm_group_label>
    <arm_group_label>B2-D-A-C-B1</arm_group_label>
    <arm_group_label>C-B1-D-A-B2</arm_group_label>
    <arm_group_label>C-D-B1-B2-A</arm_group_label>
    <arm_group_label>D-B2-C-A-B1</arm_group_label>
    <arm_group_label>D-C-B2-B1-A</arm_group_label>
    <other_name>budesonide/formoterol with coadministration of charcoal</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          -  Male or female 18 to 45 years of age.&#xD;
&#xD;
          -  If female, is currently not pregnant/breast feeding/ or attempting to become pregnant&#xD;
             has a negative serum pregnancy test, or is of non-childbearing potential or is of&#xD;
             child-bearing potential, willing to commit to using a consistent and acceptable method&#xD;
             of birth control or is of child-bearing potential and not sexually active&#xD;
&#xD;
          -  Body mass index (BMI) of 18.5 to 29.9 kg/m² inclusive and a body weight ≥50 kg.&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          -  FEV1 value less than 80% of the predicted value and FEV1/FVC ratio &lt;0.7.&#xD;
&#xD;
          -  History or current evidence of a clinically significant disease or disorder capable of&#xD;
             altering the absorption, metabolism, distribution or elimination of drugs.&#xD;
&#xD;
          -  History or current evidence of a clinically significant disease including, but not&#xD;
             limited to: cardiovascular, hepatic, renal, haematological, neuropsychological,&#xD;
             endocrine, gastrointestinal or pulmonary.&#xD;
&#xD;
          -  Presence of glaucoma, cataracts, ocular herpes simplex, malignancy, regardless of the&#xD;
             clinical significance or current stability of the disease.&#xD;
&#xD;
          -  History or presence of silent infections, including positive tests for HIV1, HIV2,&#xD;
             Hepatitis B and Hepatitis C.&#xD;
&#xD;
          -  Bacterial or viral infection of the upper respiratory tract (including the common cold&#xD;
             and flu), sinus, or middle ear within 2 weeks of dosing.&#xD;
&#xD;
          -  Lower respiratory tract infection/pneumonia within the past 3 months.&#xD;
&#xD;
          -  Presence of any disease or condition or regular concomitant treatment (including&#xD;
             vitamins and herbal products) known to interfere with the absorption, distribution,&#xD;
             metabolism or excretion of drugs.&#xD;
&#xD;
          -  Screening haemoglobin value of less than 1g/dL above the ULN (or 10g/L)&#xD;
&#xD;
          -  History of recurrent vasovagal collapses.&#xD;
&#xD;
          -  History of anaphylactic/anaphylactoid reactions.&#xD;
&#xD;
          -  History of seizures including febrile seizures excluding childhood febrile&#xD;
             convulsions.&#xD;
&#xD;
          -  Unable to demonstrate proper inhalation techniques involved in using the delivery&#xD;
             devices at screening.&#xD;
&#xD;
          -  Exposure to any investigational drug within 90 days of the Screening Visit.&#xD;
&#xD;
          -  Known or suspected hypersensitivity or idiosyncratic reaction to any steroid, any β2&#xD;
             agonist,or to lactose monohydrate, leucine or Tween 80.&#xD;
&#xD;
          -  History of allergy to milk protein.&#xD;
&#xD;
          -  Use of an inhaled corticosteroid within 30 days or systemic corticosteroid within 60&#xD;
             days of the Screening Visit.&#xD;
&#xD;
          -  Use of medications or herbal medicines that are strong cytochrome P450 3A4 (CYP3A4)&#xD;
             inhibitors or inducers within 30 days prior to Screening Visit&#xD;
&#xD;
          -  Any clinically significant abnormal laboratory value or physical finding that may&#xD;
             interfere with the interpretation of test results or cause a health risk for the&#xD;
             subject if he/she participates in the study.&#xD;
&#xD;
          -  Use of caffeine containing beverages more than 600 mg of caffeine/day.&#xD;
&#xD;
          -  Current smokers or ex-smokers who have stopped smoking for less than 10 years.&#xD;
&#xD;
          -  Recent or current (suspected) drug abuse or positive result in the drugs abuse test.&#xD;
&#xD;
          -  Recent or current alcohol abuse (regular drinking more than 21 units per week for&#xD;
             males and more than 14 units per week for females [1 unit = 4 cl spirits or&#xD;
             equivalent]).&#xD;
&#xD;
          -  Predictable poor compliance, intolerance to charcoal solution, or inability to&#xD;
             communicate well with the study centre personnel or inability to participate in all&#xD;
             treatment periods.&#xD;
&#xD;
          -  The subject is not able to understand and comply with protocol requirements,&#xD;
             instructions and protocol-stated restrictions, has participated in a clinical research&#xD;
             study within the previous three months or has previously been enrolled in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Phil Evans, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Quotient Clinical Limited</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quotient Clinical Ltd</name>
      <address>
        <city>Ruddington</city>
        <zip>NG11 6JS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <results_first_submitted>October 6, 2021</results_first_submitted>
  <results_first_submitted_qc>November 15, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 26, 2022</results_first_posted>
  <last_update_submitted>February 9, 2022</last_update_submitted>
  <last_update_submitted_qc>February 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Budesonide</mesh_term>
    <mesh_term>Formoterol Fumarate</mesh_term>
    <mesh_term>Budesonide, Formoterol Fumarate Drug Combination</mesh_term>
    <mesh_term>Charcoal</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were screened for eligibility -28 to -2 days prior to the first treatment period. On Day -1 of the first treatment period, i.d. before randomization, subjects were trained on both the RS01 and Symbicort Turbohaler devices.</recruitment_details>
      <pre_assignment_details>Subjects had to have an adequate inspiratory flow rate and be able to use both inhalers. Subjects who continued to meet all entry criteria on Day -1 of treatment Period 1 and with an inspiratory flow rate of ≥60 L/min and proper device use entered the treatment phase.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>A-B1-B2-C-D</title>
          <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B1: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period ≥5 days followed treatment periods 1 to 4.&#xD;
Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).&#xD;
Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).&#xD;
Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).&#xD;
Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D).</description>
        </group>
        <group group_id="P2">
          <title>B1-C-A-D-B2</title>
          <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B1: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period ≥5 days followed treatment periods 1 to 4.&#xD;
Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).&#xD;
Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).&#xD;
Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).&#xD;
Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D).</description>
        </group>
        <group group_id="P3">
          <title>C-D-B1-B2-A</title>
          <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B1: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period ≥5 days followed treatment periods 1 to 4.&#xD;
Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).&#xD;
Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).&#xD;
Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).&#xD;
Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D).</description>
        </group>
        <group group_id="P4">
          <title>D-B2-C-A-B1</title>
          <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B1: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period ≥5 days followed treatment periods 1 to 4.&#xD;
Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).&#xD;
Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).&#xD;
Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).&#xD;
Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D).</description>
        </group>
        <group group_id="P5">
          <title>B2-A-D-B1-C</title>
          <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B1: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period ≥5 days followed treatment periods 1 to 4.&#xD;
Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).&#xD;
Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).&#xD;
Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).&#xD;
Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D).</description>
        </group>
        <group group_id="P6">
          <title>D-C-B2-B1-A</title>
          <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B1: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period ≥5 days followed treatment periods 1 to 4.&#xD;
Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).&#xD;
Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).&#xD;
Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).&#xD;
Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D).</description>
        </group>
        <group group_id="P7">
          <title>B2-D-A-C-B1</title>
          <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B1: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period ≥5 days followed treatment periods 1 to 4.&#xD;
Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).&#xD;
Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).&#xD;
Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).&#xD;
Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D).</description>
        </group>
        <group group_id="P8">
          <title>A-B2-B1-D-C</title>
          <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B1: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period ≥5 days followed treatment periods 1 to 4.&#xD;
Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).&#xD;
Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).&#xD;
Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).&#xD;
Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D).</description>
        </group>
        <group group_id="P9">
          <title>B1-A-C-B2-D</title>
          <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B1: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period ≥5 days followed treatment periods 1 to 4.&#xD;
Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).&#xD;
Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).&#xD;
Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).&#xD;
Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D).</description>
        </group>
        <group group_id="P10">
          <title>C-B1-D-A-B2</title>
          <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B1: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period ≥5 days followed treatment periods 1 to 4.&#xD;
Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).&#xD;
Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).&#xD;
Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).&#xD;
Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="9"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="9"/>
                <participants group_id="P7" count="9"/>
                <participants group_id="P8" count="9"/>
                <participants group_id="P9" count="9"/>
                <participants group_id="P10" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>A</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="8"/>
                <participants group_id="P7" count="8"/>
                <participants group_id="P8" count="9"/>
                <participants group_id="P9" count="9"/>
                <participants group_id="P10" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>B1</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="9"/>
                <participants group_id="P7" count="9"/>
                <participants group_id="P8" count="9"/>
                <participants group_id="P9" count="9"/>
                <participants group_id="P10" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>B2</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="9"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="9"/>
                <participants group_id="P7" count="9"/>
                <participants group_id="P8" count="9"/>
                <participants group_id="P9" count="8"/>
                <participants group_id="P10" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>C</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="9"/>
                <participants group_id="P7" count="9"/>
                <participants group_id="P8" count="9"/>
                <participants group_id="P9" count="9"/>
                <participants group_id="P10" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>D</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="9"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="9"/>
                <participants group_id="P7" count="9"/>
                <participants group_id="P8" count="9"/>
                <participants group_id="P9" count="8"/>
                <participants group_id="P10" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="8"/>
                <participants group_id="P7" count="8"/>
                <participants group_id="P8" count="9"/>
                <participants group_id="P9" count="8"/>
                <participants group_id="P10" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population: All subjects who received at least one dose (2 inhalations) of investigational medicinal product.</population>
      <group_list>
        <group group_id="B1">
          <title>A-B1-B2-C-D</title>
          <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B1: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period ≥5 days followed treatment periods 1 to 4.&#xD;
Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).&#xD;
Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).&#xD;
Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).&#xD;
Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D).</description>
        </group>
        <group group_id="B2">
          <title>B1-C-A-D-B2</title>
          <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B1: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period ≥5 days followed treatment periods 1 to 4.&#xD;
Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).&#xD;
Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).&#xD;
Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).&#xD;
Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D).</description>
        </group>
        <group group_id="B3">
          <title>C-D-B1-B2-A</title>
          <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B1: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period ≥5 days followed treatment periods 1 to 4.&#xD;
Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).&#xD;
Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).&#xD;
Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).&#xD;
Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D).</description>
        </group>
        <group group_id="B4">
          <title>D-B2-C-A-B1</title>
          <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B1: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period ≥5 days followed treatment periods 1 to 4.&#xD;
Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).&#xD;
Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).&#xD;
Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).&#xD;
Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D).</description>
        </group>
        <group group_id="B5">
          <title>B2-A-D-B1-C</title>
          <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B1: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period ≥5 days followed treatment periods 1 to 4.&#xD;
Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).&#xD;
Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).&#xD;
Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).&#xD;
Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D).</description>
        </group>
        <group group_id="B6">
          <title>D-C-B2-B1-A</title>
          <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B1: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period ≥5 days followed treatment periods 1 to 4.&#xD;
Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).&#xD;
Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).&#xD;
Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).&#xD;
Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D).</description>
        </group>
        <group group_id="B7">
          <title>B2-D-A-C-B1</title>
          <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B1: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period ≥5 days followed treatment periods 1 to 4.&#xD;
Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).&#xD;
Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).&#xD;
Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).&#xD;
Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D).</description>
        </group>
        <group group_id="B8">
          <title>A-B2-B1-D-C</title>
          <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B1: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period ≥5 days followed treatment periods 1 to 4.&#xD;
Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).&#xD;
Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).&#xD;
Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).&#xD;
Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D).</description>
        </group>
        <group group_id="B9">
          <title>B1-A-C-B2-D</title>
          <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B1: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period ≥5 days followed treatment periods 1 to 4.&#xD;
Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).&#xD;
Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).&#xD;
Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).&#xD;
Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D).</description>
        </group>
        <group group_id="B10">
          <title>C-B1-D-A-B2</title>
          <description>Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:&#xD;
Treatment A: Z7200 without oral activated charcoal&#xD;
Treatment B1: Symbicort 1 without oral activated charcoal&#xD;
Treatment B1: Symbicort 2 without oral activated charcoal&#xD;
Treatment C: Z7200 with oral activated charcoal&#xD;
Treatment D: Symbicort with oral activated charcoal&#xD;
A washout period ≥5 days followed treatment periods 1 to 4.&#xD;
Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).&#xD;
Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).&#xD;
Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).&#xD;
Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D).</description>
        </group>
        <group group_id="B11">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="9"/>
            <count group_id="B4" value="9"/>
            <count group_id="B5" value="9"/>
            <count group_id="B6" value="9"/>
            <count group_id="B7" value="9"/>
            <count group_id="B8" value="9"/>
            <count group_id="B9" value="9"/>
            <count group_id="B10" value="9"/>
            <count group_id="B11" value="90"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="9"/>
                    <measurement group_id="B8" value="9"/>
                    <measurement group_id="B9" value="9"/>
                    <measurement group_id="B10" value="9"/>
                    <measurement group_id="B11" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.0" spread="7.9"/>
                    <measurement group_id="B2" value="24.7" spread="6.5"/>
                    <measurement group_id="B3" value="27.2" spread="6.0"/>
                    <measurement group_id="B4" value="28.1" spread="7.4"/>
                    <measurement group_id="B5" value="26.3" spread="7.6"/>
                    <measurement group_id="B6" value="29.8" spread="8.5"/>
                    <measurement group_id="B7" value="28.0" spread="7.6"/>
                    <measurement group_id="B8" value="28.3" spread="5.9"/>
                    <measurement group_id="B9" value="27.8" spread="8.9"/>
                    <measurement group_id="B10" value="36.2" spread="5.0"/>
                    <measurement group_id="B11" value="28.5" spread="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="3"/>
                    <measurement group_id="B9" value="5"/>
                    <measurement group_id="B10" value="4"/>
                    <measurement group_id="B11" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="4"/>
                    <measurement group_id="B10" value="5"/>
                    <measurement group_id="B11" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="3"/>
                    <measurement group_id="B11" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="7"/>
                    <measurement group_id="B8" value="9"/>
                    <measurement group_id="B9" value="8"/>
                    <measurement group_id="B10" value="6"/>
                    <measurement group_id="B11" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="9"/>
                    <measurement group_id="B8" value="9"/>
                    <measurement group_id="B9" value="9"/>
                    <measurement group_id="B10" value="9"/>
                    <measurement group_id="B11" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>AUC0-t of Budesonide With and Without Charcoal Blockade</title>
        <description>Area under the plasma concentration-time curve from time zero to the last detectable level calculations were performed using the linear trapezoidal rule.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
        <time_frame>0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)</time_frame>
        <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Z7200 without charcoal (160 ug budesonide)</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Symbicort 1+2 without charcoal (320 ug budesonide)</description>
          </group>
          <group group_id="O3">
            <title>Treatment C</title>
            <description>Z7200 with charcoal (160 ug budesonide)</description>
          </group>
          <group group_id="O4">
            <title>Treatment D</title>
            <description>Symbicort with charcoal (320 ug budesonide)</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-t of Budesonide With and Without Charcoal Blockade</title>
          <description>Area under the plasma concentration-time curve from time zero to the last detectable level calculations were performed using the linear trapezoidal rule.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
          <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
          <units>pg*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="164"/>
                <count group_id="O3" value="84"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1870" spread="20.2"/>
                    <measurement group_id="O2" value="1360" spread="49.4"/>
                    <measurement group_id="O3" value="1810" spread="22.3"/>
                    <measurement group_id="O4" value="1330" spread="52.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:&#xD;
the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and&#xD;
the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted geometric means ratio</param_type>
            <param_value>138.87</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>129.09</ci_lower_limit>
            <ci_upper_limit>149.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:&#xD;
the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and&#xD;
the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted geometric means ratio</param_type>
            <param_value>136.18</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>126.13</ci_lower_limit>
            <ci_upper_limit>147.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0-t of Formoterol With and Without Charcoal Blockade</title>
        <description>Area under the plasma concentration-time curve from time zero to the last detectable level calculations were performed using the linear trapezoidal rule.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
        <time_frame>0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)</time_frame>
        <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Z7200 without charcoal (4.5 ug formoterol)</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Symbicort 1+2 without charcoal (9 ug formoterol)</description>
          </group>
          <group group_id="O3">
            <title>Treatment C</title>
            <description>Z7200 with charcoal (4.5 ug formoterol)</description>
          </group>
          <group group_id="O4">
            <title>Treatment D</title>
            <description>Symbicort with charcoal (9 ug formoterol)</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-t of Formoterol With and Without Charcoal Blockade</title>
          <description>Area under the plasma concentration-time curve from time zero to the last detectable level calculations were performed using the linear trapezoidal rule.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
          <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
          <units>pg*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="164"/>
                <count group_id="O3" value="84"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.4" spread="26.0"/>
                    <measurement group_id="O2" value="40.1" spread="58.6"/>
                    <measurement group_id="O3" value="44.7" spread="26.8"/>
                    <measurement group_id="O4" value="34.5" spread="78.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:&#xD;
the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and&#xD;
the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade.</non_inferiority_desc>
            <p_value>0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted geometric means ratio</param_type>
            <param_value>119.73</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>109.40</ci_lower_limit>
            <ci_upper_limit>131.03</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:&#xD;
the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and&#xD;
the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted geometric means ratio</param_type>
            <param_value>129.62</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>117.33</ci_lower_limit>
            <ci_upper_limit>143.20</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Budesonide With and Without Charcoal Blockade</title>
        <description>Maximum plasma level of budesonide with and without charcoal blockade. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
        <time_frame>0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)</time_frame>
        <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Z7200 without charcoal (160 ug budesonide)</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Symbicort 1+2 without charcoal (320 ug budesonide)</description>
          </group>
          <group group_id="O3">
            <title>Treatment C</title>
            <description>Z7200 with charcoal (160 ug budesonide)</description>
          </group>
          <group group_id="O4">
            <title>Treatment D</title>
            <description>Symbicort with charcoal (320 ug budesonide)</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Budesonide With and Without Charcoal Blockade</title>
          <description>Maximum plasma level of budesonide with and without charcoal blockade. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
          <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
          <units>pg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="164"/>
                <count group_id="O3" value="84"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1040" spread="67.7"/>
                    <measurement group_id="O2" value="482" spread="63.4"/>
                    <measurement group_id="O3" value="1090" spread="78.9"/>
                    <measurement group_id="O4" value="542" spread="62.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:&#xD;
the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and&#xD;
the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted geometric means ratio</param_type>
            <param_value>218.13</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>194.02</ci_lower_limit>
            <ci_upper_limit>245.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:&#xD;
the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and&#xD;
the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted geometric means ratio</param_type>
            <param_value>200.66</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>174.30</ci_lower_limit>
            <ci_upper_limit>231.01</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Formoterol With and Without Charcoal Blockade</title>
        <description>Maximum plasma level of formoterol with and without charcoal blockade. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
        <time_frame>0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)</time_frame>
        <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Z7200 without charcoal (4.5 ug formoterol)</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Symbicort 1+2 without charcoal (9 ug formoterol)</description>
          </group>
          <group group_id="O3">
            <title>Treatment C</title>
            <description>Z7200 with charcoal (4.5 ug formoterol)</description>
          </group>
          <group group_id="O4">
            <title>Treatment D</title>
            <description>Symbicort with charcoal (9 ug formoterol)</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Formoterol With and Without Charcoal Blockade</title>
          <description>Maximum plasma level of formoterol with and without charcoal blockade. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
          <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
          <units>pg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="164"/>
                <count group_id="O3" value="84"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9" spread="38.6"/>
                    <measurement group_id="O2" value="9.53" spread="57.5"/>
                    <measurement group_id="O3" value="12.4" spread="35.5"/>
                    <measurement group_id="O4" value="10.6" spread="58.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:&#xD;
the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and&#xD;
the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted geometric means ratio</param_type>
            <param_value>126.17</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>115.93</ci_lower_limit>
            <ci_upper_limit>137.32</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:&#xD;
the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and&#xD;
the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade.</non_inferiority_desc>
            <p_value>0.004</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted geometric means ratio</param_type>
            <param_value>117.08</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>107.05</ci_lower_limit>
            <ci_upper_limit>128.05</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC0-30 of Budesonide With and Without Charcoal Blockade.</title>
        <description>Area under the plasma concentration-time curve from time zero to 30 minutes calculations were performed using the linear trapezoidal rule.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
        <time_frame>0-30 min (0, 2, 5, 10, 15, 20, and 30 min)</time_frame>
        <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Z7200 without charcoal (160 ug budesonide)</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Symbicort 1+2 without charcoal (320 ug budesonide)</description>
          </group>
          <group group_id="O3">
            <title>Treatment C</title>
            <description>Z7200 with charcoal (160 ug budesonide)</description>
          </group>
          <group group_id="O4">
            <title>Treatment D</title>
            <description>Symbicort with charcoal (320 ug budesonide)</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-30 of Budesonide With and Without Charcoal Blockade.</title>
          <description>Area under the plasma concentration-time curve from time zero to 30 minutes calculations were performed using the linear trapezoidal rule.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
          <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
          <units>pg*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="164"/>
                <count group_id="O3" value="84"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="324" spread="36.5"/>
                    <measurement group_id="O2" value="174" spread="62.0"/>
                    <measurement group_id="O3" value="342" spread="38.3"/>
                    <measurement group_id="O4" value="193" spread="63.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC0-30 of Formoterol With and Without Charcoal Blockade.</title>
        <description>Area under the plasma concentration-time curve from time zero to 30 minutes calculations were performed using the linear trapezoidal rule.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
        <time_frame>0-30 min (0, 2, 5, 10, 15, 20, and 30 min)</time_frame>
        <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Z7200 without charcoal (4.5 ug formoterol)</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Symbicort 1+2 without charcoal (9 ug formoterol)</description>
          </group>
          <group group_id="O3">
            <title>Treatment C</title>
            <description>Z7200 with charcoal (4.5 ug formoterol)</description>
          </group>
          <group group_id="O4">
            <title>Treatment D</title>
            <description>Symbicort with charcoal (9 ug formoterol)</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-30 of Formoterol With and Without Charcoal Blockade.</title>
          <description>Area under the plasma concentration-time curve from time zero to 30 minutes calculations were performed using the linear trapezoidal rule.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
          <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
          <units>pg*h/mL</units>
          <param>Geometric Least Squares Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="164"/>
                <count group_id="O3" value="84"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.85" spread="33.0"/>
                    <measurement group_id="O2" value="3.12" spread="54.4"/>
                    <measurement group_id="O3" value="4.00" spread="32.1"/>
                    <measurement group_id="O4" value="3.35" spread="58.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC0-∞ of Budesonide With and Without Charcoal Blockade</title>
        <description>Area under the plasma concentration-time curve from time zero to infinity calculations were performed using the linear trapezoidal rule.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
        <time_frame>0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)</time_frame>
        <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Z7200 without charcoal (160 ug budesonide)</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Symbicort 1+2 without charcoal (320 ug budesonide)</description>
          </group>
          <group group_id="O3">
            <title>Treatment C</title>
            <description>Z7200 with charcoal (160 ug budesonide)</description>
          </group>
          <group group_id="O4">
            <title>Treatment D</title>
            <description>Symbicort with charcoal (320 ug budesonide)</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-∞ of Budesonide With and Without Charcoal Blockade</title>
          <description>Area under the plasma concentration-time curve from time zero to infinity calculations were performed using the linear trapezoidal rule.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
          <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
          <units>pg*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="163"/>
                <count group_id="O3" value="84"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1980" spread="20.5"/>
                    <measurement group_id="O2" value="1450" spread="48.8"/>
                    <measurement group_id="O3" value="1900" spread="22.4"/>
                    <measurement group_id="O4" value="1410" spread="50.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC0-∞ of Formoterol With and Without Charcoal Blockade</title>
        <description>Area under the plasma concentration-time curve from time zero to infinity calculations were performed using the linear trapezoidal rule.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
        <time_frame>0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)</time_frame>
        <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Z7200 without charcoal (4.5 ug formoterol)</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Symbicort 1+2 without charcoal (9 ug formoterol)</description>
          </group>
          <group group_id="O3">
            <title>Treatment C</title>
            <description>Z7200 with charcoal (4.5 ug formoterol)</description>
          </group>
          <group group_id="O4">
            <title>Treatment D</title>
            <description>Symbicort with charcoal (9 ug formoterol)</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-∞ of Formoterol With and Without Charcoal Blockade</title>
          <description>Area under the plasma concentration-time curve from time zero to infinity calculations were performed using the linear trapezoidal rule.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
          <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
          <units>pg*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="126"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.0" spread="28.2"/>
                    <measurement group_id="O2" value="49.8" spread="57.1"/>
                    <measurement group_id="O3" value="54.5" spread="27.7"/>
                    <measurement group_id="O4" value="45.2" spread="61.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax for Budesonide With and Without Charcoal Blockade</title>
        <description>Time at which the maximum plasma level (Cmax) occurred with and without charcoal blockade.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
        <time_frame>0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)</time_frame>
        <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Z7200 without charcoal (160 ug budesonide)</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Symbicort 1+2 without charcoal (320 ug budesonide)</description>
          </group>
          <group group_id="O3">
            <title>Treatment C</title>
            <description>Z7200 with charcoal (160 ug budesonide)</description>
          </group>
          <group group_id="O4">
            <title>Treatment D</title>
            <description>Symbicort with charcoal (320 ug budesonide)</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax for Budesonide With and Without Charcoal Blockade</title>
          <description>Time at which the maximum plasma level (Cmax) occurred with and without charcoal blockade.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
          <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="164"/>
                <count group_id="O3" value="84"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" lower_limit="0.03" upper_limit="0.75"/>
                    <measurement group_id="O2" value="0.25" lower_limit="0.03" upper_limit="1.50"/>
                    <measurement group_id="O3" value="0.08" lower_limit="0.03" upper_limit="0.75"/>
                    <measurement group_id="O4" value="0.25" lower_limit="0.03" upper_limit="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax for Formoterol With and Without Charcoal Blockade</title>
        <description>Time at which the maximum plasma level (Cmax) occurred with and without charcoal blockade.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
        <time_frame>0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)</time_frame>
        <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Z7200 without charcoal (4.5 ug formoterol)</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Symbicort 1+2 without charcoal (9 ug formoterol)</description>
          </group>
          <group group_id="O3">
            <title>Treatment C</title>
            <description>Z7200 with charcoal (4.5 ug formoterol)</description>
          </group>
          <group group_id="O4">
            <title>Treatment D</title>
            <description>Symbicort with charcoal (9 ug formoterol)</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax for Formoterol With and Without Charcoal Blockade</title>
          <description>Time at which the maximum plasma level (Cmax) occurred with and without charcoal blockade.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
          <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="164"/>
                <count group_id="O3" value="84"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" lower_limit="0.08" upper_limit="0.20"/>
                    <measurement group_id="O2" value="0.08" lower_limit="0.04" upper_limit="0.25"/>
                    <measurement group_id="O3" value="0.08" lower_limit="0.03" upper_limit="0.17"/>
                    <measurement group_id="O4" value="0.08" lower_limit="0.08" upper_limit="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>t1/2 for Budesonide With and Without Charcoal Blockade</title>
        <description>Apparent elimination half-life calculated as 0.693/lambda zeta, with and without charcoal blockade.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
        <time_frame>0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)</time_frame>
        <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Z7200 without charcoal (160 ug budesonide)</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Symbicort 1+2 without charcoal (320 ug budesonide)</description>
          </group>
          <group group_id="O3">
            <title>Treatment C</title>
            <description>Z7200 with charcoal (160 ug budesonide)</description>
          </group>
          <group group_id="O4">
            <title>Treatment D</title>
            <description>Symbicort with charcoal (320 ug budesonide)</description>
          </group>
        </group_list>
        <measure>
          <title>t1/2 for Budesonide With and Without Charcoal Blockade</title>
          <description>Apparent elimination half-life calculated as 0.693/lambda zeta, with and without charcoal blockade.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
          <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
          <units>hours</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="163"/>
                <count group_id="O3" value="84"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.90" spread="17.0"/>
                    <measurement group_id="O2" value="2.94" spread="19.8"/>
                    <measurement group_id="O3" value="2.79" spread="17.0"/>
                    <measurement group_id="O4" value="2.80" spread="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>t1/2 for Formoterol With and Without Charcoal Blockade</title>
        <description>Apparent elimination half-life calculated as 0.693/lambda zeta, with and without charcoal blockade.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
        <time_frame>0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)</time_frame>
        <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Z7200 without charcoal (160 ug budesonide)</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Symbicort 1+2 without charcoal (320 ug budesonide)</description>
          </group>
          <group group_id="O3">
            <title>Treatment C</title>
            <description>Z7200 with charcoal (160 ug budesonide)</description>
          </group>
          <group group_id="O4">
            <title>Treatment D</title>
            <description>Symbicort with charcoal (320 ug budesonide)</description>
          </group>
        </group_list>
        <measure>
          <title>t1/2 for Formoterol With and Without Charcoal Blockade</title>
          <description>Apparent elimination half-life calculated as 0.693/lambda zeta, with and without charcoal blockade.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.</description>
          <population>PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal.</population>
          <units>hours</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="126"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.57" spread="29.3"/>
                    <measurement group_id="O2" value="9.33" spread="35.2"/>
                    <measurement group_id="O3" value="10.09" spread="29.8"/>
                    <measurement group_id="O4" value="9.15" spread="33.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)</title>
        <description>FEV1 refers to the volume of air that an individual can exhale during a forced breath in 1 second.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.&#xD;
and Symbicort 2, together. Please note that, within the safety population, 90 subjects received Treatment B. This would mean that theorically 180 participants received Symbicort 1 and Symbicort 2, together.&#xD;
But some subjects were excluded from the statistical analysis for various reasons so that the total number included in the statistical anlysis for treatment B is 174.</description>
        <time_frame>At 75 min (1.25 hours) post-dose</time_frame>
        <population>Safety population: all subjects who received at least one dose (2 inhalations) of investigational medicinal product</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Z7200 without charcoal</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Symbicort 1+2 without charcoal</description>
          </group>
          <group group_id="O3">
            <title>Treatment C</title>
            <description>Z7200 with charcoal</description>
          </group>
          <group group_id="O4">
            <title>Treatment D</title>
            <description>Symbicort with charcoal</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)</title>
          <description>FEV1 refers to the volume of air that an individual can exhale during a forced breath in 1 second.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.&#xD;
and Symbicort 2, together. Please note that, within the safety population, 90 subjects received Treatment B. This would mean that theorically 180 participants received Symbicort 1 and Symbicort 2, together.&#xD;
But some subjects were excluded from the statistical analysis for various reasons so that the total number included in the statistical anlysis for treatment B is 174.</description>
          <population>Safety population: all subjects who received at least one dose (2 inhalations) of investigational medicinal product</population>
          <units>liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="174"/>
                <count group_id="O3" value="87"/>
                <count group_id="O4" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.2"/>
                    <measurement group_id="O2" value="0.2" spread="0.2"/>
                    <measurement group_id="O3" value="0.2" spread="0.2"/>
                    <measurement group_id="O4" value="0.2" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Ratio of Forced Expiratory Volume in 1 Second to Forced Vital Capacity (FEV1/FVC)</title>
        <description>FVC = Forced vital capacity. It is the full amount of air that can be exhaled with effort in a complete breath.&#xD;
FEV1/FVC = Tiffenau-Pinelli Index. This parameter represents the measurement of the amount of air an individual can forcefully exhale from his/her lungs.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.&#xD;
Please note that, within the safety population, 90 subjects received Treatment B. This would mean that theorically 180 participants received Symbicort 1 and Symbicort 2, together.&#xD;
But 6 subjects were excluded from the statistical analysis for various reasons so that the total number included in the statistical anlysis for treatment B is 174.</description>
        <time_frame>At 75 min (1.25 hours) post-dose</time_frame>
        <population>Safety population: all subjects who received at least one dose (2 inhalations) of investigational medicinal product.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Z7200 without charcoal</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Symbicort 1+2 without charcoal</description>
          </group>
          <group group_id="O3">
            <title>Treatment C</title>
            <description>Z7200 with charcoal</description>
          </group>
          <group group_id="O4">
            <title>Treatment D</title>
            <description>Symbicort with charcoal</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Ratio of Forced Expiratory Volume in 1 Second to Forced Vital Capacity (FEV1/FVC)</title>
          <description>FVC = Forced vital capacity. It is the full amount of air that can be exhaled with effort in a complete breath.&#xD;
FEV1/FVC = Tiffenau-Pinelli Index. This parameter represents the measurement of the amount of air an individual can forcefully exhale from his/her lungs.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.&#xD;
Please note that, within the safety population, 90 subjects received Treatment B. This would mean that theorically 180 participants received Symbicort 1 and Symbicort 2, together.&#xD;
But 6 subjects were excluded from the statistical analysis for various reasons so that the total number included in the statistical anlysis for treatment B is 174.</description>
          <population>Safety population: all subjects who received at least one dose (2 inhalations) of investigational medicinal product.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="174"/>
                <count group_id="O3" value="87"/>
                <count group_id="O4" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="3.0"/>
                    <measurement group_id="O2" value="3.6" spread="3.4"/>
                    <measurement group_id="O3" value="3.2" spread="3.1"/>
                    <measurement group_id="O4" value="3.8" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Peak Expiratory Flow Rate (PEFR)</title>
        <description>PEFR is the highest rate at which gases can be expelled from the lungs via an open mouth. Its measurement is a simple procedure in which an individual takes a full inspiration and blows out as forcibly as possible into an instrument called a peak flow meter, which measures the maximal gas flow in an exhalation in liters per minute.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.Please note that, within the safety population, 90 subjects received Treatment B. This would mean that theorically 180 participants received Symbicort 1 and Symbicort 2, together. But 6 subjects were excluded from the statistical analysis for various reasons so that the total number included in the statistical anlysis for treatment B is 174.</description>
        <time_frame>At 75 min (1.25 hours) post-dose</time_frame>
        <population>Safety population: all subjects who received at least one dose (2 inhalations) of investigational medicinal product.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Z7200 without charcoal</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Symbicort 1+2 without charcoal</description>
          </group>
          <group group_id="O3">
            <title>Treatment C</title>
            <description>Z7200 with charcoal</description>
          </group>
          <group group_id="O4">
            <title>Treatment D</title>
            <description>Symbicort with charcoal</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Peak Expiratory Flow Rate (PEFR)</title>
          <description>PEFR is the highest rate at which gases can be expelled from the lungs via an open mouth. Its measurement is a simple procedure in which an individual takes a full inspiration and blows out as forcibly as possible into an instrument called a peak flow meter, which measures the maximal gas flow in an exhalation in liters per minute.&#xD;
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.Please note that, within the safety population, 90 subjects received Treatment B. This would mean that theorically 180 participants received Symbicort 1 and Symbicort 2, together. But 6 subjects were excluded from the statistical analysis for various reasons so that the total number included in the statistical anlysis for treatment B is 174.</description>
          <population>Safety population: all subjects who received at least one dose (2 inhalations) of investigational medicinal product.</population>
          <units>L/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="174"/>
                <count group_id="O3" value="87"/>
                <count group_id="O4" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2" spread="48.9"/>
                    <measurement group_id="O2" value="20.5" spread="38.7"/>
                    <measurement group_id="O3" value="24.8" spread="35.5"/>
                    <measurement group_id="O4" value="19.2" spread="38.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Throughout the study till the end of trial assessment, which was completed on Day 2 of last treatment period (up to 6 weeks).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment A</title>
          <description>Z7200 without charcoal</description>
        </group>
        <group group_id="E2">
          <title>Treatment B</title>
          <description>Symbicort 1+2 without charcoal</description>
        </group>
        <group group_id="E3">
          <title>Treatment C</title>
          <description>Z7200 with charcoal</description>
        </group>
        <group group_id="E4">
          <title>Treatment D</title>
          <description>Symbicort with charcoal</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="90"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="88"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Oral Discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Oral Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site related reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Axillary pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Vessel puncture site swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Thooth abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Thermal Burn</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Eosinophil count increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Blood pressure systolic increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Limb discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="84"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Migrane</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Euphoric mood</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Limitations and Caveats not specified</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Isabella Salerio, PhD</name_or_title>
      <organization>Zambon SpA</organization>
      <phone>+39 02665241</phone>
      <email>clinicaltrials@zambongroup.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02237508
org study id: Z7200J02
secondary id: 2014-002081-69
nct id: NCT02237508
lead sponsor: 
has dmc: No
The primary objective was:

      - to assess the bioequivalence of a single dose (two inhalations) of the test product
      compared to the reference product, with and without charcoal blockade.

      The secondary objectives were:

        -  to assess the pharmacokinetic profile of budesonide and formoterol in plasma after a
           single dose (two inhalations) of the test product and the reference product, with and
           without charcoal blockade.

        -  to assess the safety and tolerability of the test product and the reference product,
           with and without charcoal blockade.
This was a single center, open label, randomized, five-period crossover, single-dose study in
      healthy volunteers aged 18 to 45 years. A total of 90 volunteers were enrolled, with 9
      subjects in each of the 10 treatment sequences.

      The study consisted of 5 treatment periods, each lasting approximately 48h, separated by a
      washout period of a minimum of 5 days. RS01 and/or Symbicort Turbohaler device use training
      was provided on Day -1 and Day 1 of each treatment period. Subjects were screened for
      eligibility to participate in the study -28 to -2 days prior to the first treatment period,
      and were randomized to one of 10 treatment sequencies containing the following 5 treatment
      arms on Day 1 of the first treatment period:

      Treatment A: Z7200 without oral activated charcoal* Treatment B1: Symbicort 1 without oral
      activated charcoal* Treatment B2: Symbicort 2 without oral activated charcoal* Treatment C:
      Z7200 with oral activated charcoal** Treatment D: Symbicort with oral activated charcoal**

      Subjects were admitted to the clinical unit at 8.00 on the morning of Day -1, and were dosed
      on the morning of Day 1 following an overnight fast (minimum of 8h). On Day 2, following
      collection of the 24-h PK blood sample, subjects were discharged.

      * Subjects who received treatments A, B1 and B2 rinsed their mouth vigorously with 50 mL
      water for 3 to 5 sec immediately after the second inhalation.

      ** A charcoal blockade was used to prevent absorption from oropharyngeal and GI tract, in
      order to assess the pulmonary deposition of budesonide and formoterol, with periods performed
      without a charcoal blockade allowing the assessment of the total systemic exposure to the
      drug.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC0-t of Budesonide With and Without Charcoal Blockade
time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
description: Area under the plasma concentration-time curve from time zero to the last detectable level calculations were performed using the linear trapezoidal rule.
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
measure: AUC0-t of Formoterol With and Without Charcoal Blockade
time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
description: Area under the plasma concentration-time curve from time zero to the last detectable level calculations were performed using the linear trapezoidal rule.
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
measure: Cmax of Budesonide With and Without Charcoal Blockade
time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
description: Maximum plasma level of budesonide with and without charcoal blockade. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
measure: Cmax of Formoterol With and Without Charcoal Blockade
time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
description: Maximum plasma level of formoterol with and without charcoal blockade. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
measure: AUC0-30 of Budesonide With and Without Charcoal Blockade.
time frame: 0-30 min (0, 2, 5, 10, 15, 20, and 30 min)
description: Area under the plasma concentration-time curve from time zero to 30 minutes calculations were performed using the linear trapezoidal rule.
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
measure: AUC0-30 of Formoterol With and Without Charcoal Blockade.
time frame: 0-30 min (0, 2, 5, 10, 15, 20, and 30 min)
description: Area under the plasma concentration-time curve from time zero to 30 minutes calculations were performed using the linear trapezoidal rule.
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
measure: AUC0-∞ of Budesonide With and Without Charcoal Blockade
time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
description: Area under the plasma concentration-time curve from time zero to infinity calculations were performed using the linear trapezoidal rule.
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
measure: AUC0-∞ of Formoterol With and Without Charcoal Blockade
time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
description: Area under the plasma concentration-time curve from time zero to infinity calculations were performed using the linear trapezoidal rule.
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
measure: Tmax for Budesonide With and Without Charcoal Blockade
time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
description: Time at which the maximum plasma level (Cmax) occurred with and without charcoal blockade.
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
measure: Tmax for Formoterol With and Without Charcoal Blockade
time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
description: Time at which the maximum plasma level (Cmax) occurred with and without charcoal blockade.
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
measure: t1/2 for Budesonide With and Without Charcoal Blockade
time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
description: Apparent elimination half-life calculated as 0.693/lambda zeta, with and without charcoal blockade.
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
measure: t1/2 for Formoterol With and Without Charcoal Blockade
time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
description: Apparent elimination half-life calculated as 0.693/lambda zeta, with and without charcoal blockade.
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
measure: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
time frame: At 75 min (1.25 hours) post-dose
description: FEV1 refers to the volume of air that an individual can exhale during a forced breath in 1 second.
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
and Symbicort 2, together. Please note that, within the safety population, 90 subjects received Treatment B. This would mean that theorically 180 participants received Symbicort 1 and Symbicort 2, together.
But some subjects were excluded from the statistical analysis for various reasons so that the total number included in the statistical anlysis for treatment B is 174.
measure: Change From Baseline in the Ratio of Forced Expiratory Volume in 1 Second to Forced Vital Capacity (FEV1/FVC)
time frame: At 75 min (1.25 hours) post-dose
description: FVC = Forced vital capacity. It is the full amount of air that can be exhaled with effort in a complete breath.
FEV1/FVC = Tiffenau-Pinelli Index. This parameter represents the measurement of the amount of air an individual can forcefully exhale from his/her lungs.
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
Please note that, within the safety population, 90 subjects received Treatment B. This would mean that theorically 180 participants received Symbicort 1 and Symbicort 2, together.
But 6 subjects were excluded from the statistical analysis for various reasons so that the total number included in the statistical anlysis for treatment B is 174.
measure: Change From Baseline in Peak Expiratory Flow Rate (PEFR)
time frame: At 75 min (1.25 hours) post-dose
description: PEFR is the highest rate at which gases can be expelled from the lungs via an open mouth. Its measurement is a simple procedure in which an individual takes a full inspiration and blows out as forcibly as possible into an instrument called a peak flow meter, which measures the maximal gas flow in an exhalation in liters per minute.
Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.Please note that, within the safety population, 90 subjects received Treatment B. This would mean that theorically 180 participants received Symbicort 1 and Symbicort 2, together. But 6 subjects were excluded from the statistical analysis for various reasons so that the total number included in the statistical anlysis for treatment B is 174.
arm group label: A-B1-B2-C-D
arm group type: Experimental
description: Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:
Treatment A: Z7200 without oral activated charcoal
Treatment B1: Symbicort 1 without oral activated charcoal
Treatment B2: Symbicort 2 without oral activated charcoal
Treatment C: Z7200 with oral activated charcoal
Treatment D: Symbicort with oral activated charcoal
A washout period of a minimum of 5 days followed treatment periods 1 to 4.
Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.
arm group label: B1-C-A-D-B2
arm group type: Experimental
description: Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design:
Treatment A: Z7200 without oral activated charcoal
Treatment B1: Symbicort 1 without oral activated charcoal
Treatment B2: Symbicort 2 without oral activated charcoal
Treatment C: Z7200 with oral activated charcoal
Treatment D: Symbicort with oral activated charcoal
A washout period of a minimum of 5 day followed treatment periods 1 to 4.
Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.
arm group label: C-D-B1-B2-A
arm group type: Experimental
description: Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design:
Treatment A: Z7200 without oral activated charcoal
Treatment B1: Symbicort 1 without oral activated charcoal
Treatment B2: Symbicort 2 without oral activated charcoal
Treatment C: Z7200 with oral activated charcoal
Treatment D: Symbicort with oral activated charcoal
A washout period of a minimum of 5 day followed treatment periods 1 to 4.
Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.
arm group label: D-B2-C-A-B1
arm group type: Experimental
description: Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design:
Treatment A: Z7200 without oral activated charcoal
Treatment B1: Symbicort 1 without oral activated charcoal
Treatment B2: Symbicort 2 without oral activated charcoal
Treatment C: Z7200 with oral activated charcoal
Treatment D: Symbicort with oral activated charcoal
A washout period of a minimum of 5 day followed treatment periods 1 to 4.
Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.
arm group label: B2-A-D-B1-C
arm group type: Experimental
description: Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design:
Treatment A: Z7200 without oral activated charcoal
Treatment B1: Symbicort 1 without oral activated charcoal
Treatment B2: Symbicort 2 without oral activated charcoal
Treatment C: Z7200 with oral activated charcoal
Treatment D: Symbicort with oral activated charcoal
A washout period of a minimum of 5 day followed treatment periods 1 to 4.
Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.
arm group label: D-C-B2-B1-A
arm group type: Experimental
description: Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design:
Treatment A: Z7200 without oral activated charcoal
Treatment B1: Symbicort 1 without oral activated charcoal
Treatment B2: Symbicort 2 without oral activated charcoal
Treatment C: Z7200 with oral activated charcoal
Treatment D: Symbicort with oral activated charcoal
A washout period of a minimum of 5 day followed treatment periods 1 to 4.
Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.
arm group label: B2-D-A-C-B1
arm group type: Experimental
description: Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design:
Treatment A: Z7200 without oral activated charcoal
Treatment B1: Symbicort 1 without oral activated charcoal
Treatment B2: Symbicort 2 without oral activated charcoal
Treatment C: Z7200 with oral activated charcoal
Treatment D: Symbicort with oral activated charcoal
A washout period of a minimum of 5 day followed treatment periods 1 to 4.
Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.
arm group label: A-B2-B1-D-C
arm group type: Experimental
description: Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design:
Treatment A: Z7200 without oral activated charcoal
Treatment B1: Symbicort 1 without oral activated charcoal
Treatment B2: Symbicort 2 without oral activated charcoal
Treatment C: Z7200 with oral activated charcoal
Treatment D: Symbicort with oral activated charcoal
A washout period of a minimum of 5 day followed treatment periods 1 to 4.
Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.
arm group label: B1-A-C-B2-D
arm group type: Experimental
description: Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design:
Treatment A: Z7200 without oral activated charcoal
Treatment B1: Symbicort 1 without oral activated charcoal
Treatment B2: Symbicort 2 without oral activated charcoal
Treatment C: Z7200 with oral activated charcoal
Treatment D: Symbicort with oral activated charcoal
A washout period of a minimum of 5 day followed treatment periods 1 to 4.
Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.
arm group label: C-B1-D-A-B2
arm group type: Experimental
description: Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design:
Treatment A: Z7200 without oral activated charcoal
Treatment B1: Symbicort 1 without oral activated charcoal
Treatment B2: Symbicort 2 without oral activated charcoal
Treatment C: Z7200 with oral activated charcoal
Treatment D: Symbicort with oral activated charcoal
A washout period of a minimum of 5 day followed treatment periods 1 to 4.
Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.
intervention type: Drug
intervention name: Z7200 without oral activated charcoal
description: 160 ug budesonide and 4.5 ug formoterol fumarate dihydrate, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).
arm group label: A-B1-B2-C-D
arm group label: A-B2-B1-D-C
arm group label: B1-A-C-B2-D
arm group label: B1-C-A-D-B2
arm group label: B2-A-D-B1-C
arm group label: B2-D-A-C-B1
arm group label: C-B1-D-A-B2
arm group label: C-D-B1-B2-A
arm group label: D-B2-C-A-B1
arm group label: D-C-B2-B1-A
other name: budesonide/formoterol
intervention type: Drug
intervention name: Symbicort Turbohaler without oral activated charcoal
description: 320 ug budesonide and 9 ug formoterol fumarate dihydrate, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).
arm group label: A-B1-B2-C-D
arm group label: A-B2-B1-D-C
arm group label: B1-A-C-B2-D
arm group label: B1-C-A-D-B2
arm group label: B2-A-D-B1-C
arm group label: B2-D-A-C-B1
arm group label: C-B1-D-A-B2
arm group label: C-D-B1-B2-A
arm group label: D-B2-C-A-B1
arm group label: D-C-B2-B1-A
other name: budesonide/formoterol
intervention type: Drug
intervention name: Z7200 with oral activated charcoal
description: 160 ug budesonide and 4.5 ug formoterol fumarate dihydrate, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).
arm group label: A-B1-B2-C-D
arm group label: A-B2-B1-D-C
arm group label: B1-A-C-B2-D
arm group label: B1-C-A-D-B2
arm group label: B2-A-D-B1-C
arm group label: B2-D-A-C-B1
arm group label: C-B1-D-A-B2
arm group label: C-D-B1-B2-A
arm group label: D-B2-C-A-B1
arm group label: D-C-B2-B1-A
other name: budesonide/formoterol with coadministration of charcoal
intervention type: Drug
intervention name: Symbicort Turbohaler with oral activated charcoal
description: 320 ug budesonide and 9 ug formoterol fumarate dihydrate, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation from a Symbicort Turbohaler, with charcoal blockade (Treatment D).
arm group label: A-B1-B2-C-D
arm group label: A-B2-B1-D-C
arm group label: B1-A-C-B2-D
arm group label: B1-C-A-D-B2
arm group label: B2-A-D-B1-C
arm group label: B2-D-A-C-B1
arm group label: C-B1-D-A-B2
arm group label: C-D-B1-B2-A
arm group label: D-B2-C-A-B1
arm group label: D-C-B2-B1-A
other name: budesonide/formoterol with coadministration of charcoal
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Phil Evans, MBChB
role: Principal Investigator
affiliation: Quotient Clinical Limited
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Budesonide
mesh term: Formoterol Fumarate
mesh term: Budesonide, Formoterol Fumarate Drug Combination
mesh term: Charcoal
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Limitations and Caveats not specified
point of contact: 