<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/NCT03238482</url>
  </required_header>
  <id_info>
    <org_study_id>3106012</org_study_id>
    <nct_id>NCT03238482</nct_id>
  </id_info>
  <brief_title>Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus (SAIMI)</brief_title>
  <official_title>Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler 50/250 µg/Dose Products and Seretide Diskus 50/250 µg/Dose in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orion Corporation, Orion Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Orion Corporation, Orion Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare absorption of salmeterol and fluticasone from&#xD;
      Salmeterol/fluticasone Easyhaler test products to the commercially available product Seretide&#xD;
      Diskus&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Actual">December 19, 2017</completion_date>
  <primary_completion_date type="Actual">December 19, 2017</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>Peak plasma concentration (Cmax) of salmeterol</measure>
    <time_frame>between 0-34 hours after dosing</time_frame>
    <description>Cmax of salmeterol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak plasma concentration (Cmax) of fluticasone propionate</measure>
    <time_frame>between 0-34 hours after dosing</time_frame>
    <description>Cmax of fluticasone propionate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) of salmeterol</measure>
    <time_frame>0-34 hours after dosing</time_frame>
    <description>AUC from time zero to the last sample with the quantifiable concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) of fluticasone propionate</measure>
    <time_frame>0-34 hours after dosing</time_frame>
    <description>AUC from time zero to the last sample with the quantifiable concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Truncated area under the plasma concentration versus time curve (AUC) of salmeterol</measure>
    <time_frame>0-30 minutes after dosing</time_frame>
    <description>AUC from time zero to 30 min after study treatment administration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) of salmeterol</measure>
    <time_frame>0-34 hours after dosing and extrapolation</time_frame>
    <description>AUC from time zero to infinity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) of fluticasone propionate</measure>
    <time_frame>0-34 hours after dosing and extrapolation</time_frame>
    <description>AUC from time zero to infinity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time to reach the maximum concentration (tmax) of salmeterol</measure>
    <time_frame>0-34 hours after dosing</time_frame>
    <description>tmax of salmeterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time to reach the maximum concentration (tmax) of fluticasone propionate</measure>
    <time_frame>0-34 hours after dosing</time_frame>
    <description>tmax of fluticasone propionate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The terminal elimination half-life (t1/2) of salmeterol</measure>
    <time_frame>0-34 hours after dosing</time_frame>
    <description>t1/2 of salmeterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The terminal elimination half-life (t1/2) of fluticasone propionate</measure>
    <time_frame>0-34 hours after dosing</time_frame>
    <description>t1/2 of fluticasone propionate</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse events</measure>
    <time_frame>through study completion, an average of 6 weeks</time_frame>
    <description>Adverse events</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Seretide Diskus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>salmeterol-fluticasone 2 inhalations as a single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Salmeterol/fluticasone Easyhaler, E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>salmeterol-fluticasone 2 inhalations as a single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Salmeterol/fluticasone Easyhaler, F</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>salmeterol-fluticasone 2 inhalations as a single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Salmeterol/fluticasone Easyhaler, G</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>salmeterol-fluticasone 2 inhalations as a single dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>salmeterol-fluticasone</intervention_name>
    <description>Seretide Diskus 50/250 µg/dose</description>
    <arm_group_label>Seretide Diskus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>salmeterol-fluticasone</intervention_name>
    <description>Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product E</description>
    <arm_group_label>Salmeterol/fluticasone Easyhaler, E</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>salmeterol-fluticasone</intervention_name>
    <description>Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product F</description>
    <arm_group_label>Salmeterol/fluticasone Easyhaler, F</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>salmeterol-fluticasone</intervention_name>
    <description>Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product G</description>
    <arm_group_label>Salmeterol/fluticasone Easyhaler, G</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent (IC) obtained.&#xD;
&#xD;
          2. Males and females, 18-60 (inclusive) years of age.&#xD;
&#xD;
          3. Normal weight defined as body mass index (BMI) 19-30 kg/m2 (BMI = weight/height2).&#xD;
&#xD;
          4. Weight at least 50 kg.&#xD;
&#xD;
        Main exclusion Criteria:&#xD;
&#xD;
          1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological,&#xD;
             GI, pulmonary, metabolic, endocrine, neurological or psychiatric disease.&#xD;
&#xD;
          2. Any condition requiring regular concomitant treatment.&#xD;
&#xD;
          3. Any clinically significant abnormal laboratory value or physical finding that in the&#xD;
             opinion of the investigator may interfere with the interpretation of study results or&#xD;
             constitute a health risk for the subject if he/she takes part in the study.&#xD;
&#xD;
          4. Known hypersensitivity to the active substance(s) or the lactose.&#xD;
&#xD;
          5. Pregnant or lactating females and females of childbearing potential not using proper&#xD;
             contraception.&#xD;
&#xD;
          6. Blood donation or loss of significant amount of blood within 90 days prior to first&#xD;
             study treatment administration.&#xD;
&#xD;
          7. Administration of another investigational medicinal product within 90 days prior to&#xD;
             first study treatment administration.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulla Sairanen</last_name>
    <role>Study Director</role>
    <affiliation>Orion Corporation, Orion Pharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Pharmacology Unit, Orion Pharma</name>
      <address>
        <city>Espoo</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>April 5, 2018</last_update_submitted>
  <last_update_submitted_qc>April 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2018</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>Fluticasone</mesh_term>
    <mesh_term>Xhance</mesh_term>
    <mesh_term>Salmeterol Xinafoate</mesh_term>
    <mesh_term>Fluticasone-Salmeterol Drug Combination</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03238482
org study id: 3106012
nct id: NCT03238482
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare absorption of salmeterol and fluticasone from
      Salmeterol/fluticasone Easyhaler test products to the commercially available product Seretide
      Diskus
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Peak plasma concentration (Cmax) of salmeterol
time frame: between 0-34 hours after dosing
description: Cmax of salmeterol
measure: Peak plasma concentration (Cmax) of fluticasone propionate
time frame: between 0-34 hours after dosing
description: Cmax of fluticasone propionate
measure: Area under the plasma concentration versus time curve (AUC) of salmeterol
time frame: 0-34 hours after dosing
description: AUC from time zero to the last sample with the quantifiable concentration
measure: Area under the plasma concentration versus time curve (AUC) of fluticasone propionate
time frame: 0-34 hours after dosing
description: AUC from time zero to the last sample with the quantifiable concentration
measure: Truncated area under the plasma concentration versus time curve (AUC) of salmeterol
time frame: 0-30 minutes after dosing
description: AUC from time zero to 30 min after study treatment administration
measure: Area under the plasma concentration versus time curve (AUC) of salmeterol
time frame: 0-34 hours after dosing and extrapolation
description: AUC from time zero to infinity
measure: Area under the plasma concentration versus time curve (AUC) of fluticasone propionate
time frame: 0-34 hours after dosing and extrapolation
description: AUC from time zero to infinity
measure: The time to reach the maximum concentration (tmax) of salmeterol
time frame: 0-34 hours after dosing
description: tmax of salmeterol
measure: The time to reach the maximum concentration (tmax) of fluticasone propionate
time frame: 0-34 hours after dosing
description: tmax of fluticasone propionate
measure: The terminal elimination half-life (t1/2) of salmeterol
time frame: 0-34 hours after dosing
description: t1/2 of salmeterol
measure: The terminal elimination half-life (t1/2) of fluticasone propionate
time frame: 0-34 hours after dosing
description: t1/2 of fluticasone propionate
measure: Adverse events
time frame: through study completion, an average of 6 weeks
description: Adverse events
arm group label: Seretide Diskus
arm group type: Active Comparator
description: salmeterol-fluticasone 2 inhalations as a single dose
arm group label: Salmeterol/fluticasone Easyhaler, E
arm group type: Experimental
description: salmeterol-fluticasone 2 inhalations as a single dose
arm group label: Salmeterol/fluticasone Easyhaler, F
arm group type: Experimental
description: salmeterol-fluticasone 2 inhalations as a single dose
arm group label: Salmeterol/fluticasone Easyhaler, G
arm group type: Experimental
description: salmeterol-fluticasone 2 inhalations as a single dose
intervention type: Drug
intervention name: salmeterol-fluticasone
description: Seretide Diskus 50/250 µg/dose
arm group label: Seretide Diskus
intervention type: Drug
intervention name: salmeterol-fluticasone
description: Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product E
arm group label: Salmeterol/fluticasone Easyhaler, E
intervention type: Drug
intervention name: salmeterol-fluticasone
description: Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product F
arm group label: Salmeterol/fluticasone Easyhaler, F
intervention type: Drug
intervention name: salmeterol-fluticasone
description: Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product G
arm group label: Salmeterol/fluticasone Easyhaler, G
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ulla Sairanen
role: Study Director
affiliation: Orion Corporation, Orion Pharma
facility: 
country: Finland
responsible party type: Sponsor
mesh term: Fluticasone
mesh term: Xhance
mesh term: Salmeterol Xinafoate
mesh term: Fluticasone-Salmeterol Drug Combination