<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/NCT02254187</url>
  </required_header>
  <id_info>
    <org_study_id>1184.17</org_study_id>
    <nct_id>NCT02254187</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Salmeterol Via HandiHaler® in Healthy Male Volunteers</brief_title>
  <official_title>A Randomised, Open-label Three-way Crossover Study to Evaluate the Pharmacokinetics of Salmeterol After Inhalation of a 25 μg and 50 μg Single Dose (Inhalation Powder, Hard PE Capsule for HandiHaler®2) and a 50 μg Single Dose (Serevent® Diskus®) in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The objective of this study is to investigate if the systemic drug exposure of at least 25 μg&#xD;
      and perhaps 50 μg salmeterol presented as inhalation powder in PE capsules and administered&#xD;
      via HandiHaler® 2 does not exceed that of 50 μg Serevent® Diskus® and to investigate safety&#xD;
      and tolerability of salmeterol presented as inhalation powder in PE capsules and administered&#xD;
      via HandiHaler® 2&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2005</start_date>
  <primary_completion_date type="Actual">October 2005</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-∞ (area under the concentration-time curve of salmeterol in blood plasma over the time interval from 0 extrapolated to infinity)</measure>
    <time_frame>up to 8 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (maximum measured concentration of salmeterol in blood plasma)</measure>
    <time_frame>up to 8 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of salmeterol in plasma over the time interval from 0 to the time of the last quantifiable data point)</measure>
    <time_frame>up to 8 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCt1-t2 (area under the concentration time curve of salmeterol in plasma over the time interval t1 to t2)</measure>
    <time_frame>up to 8 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to the maximum concentration of salmeterol in plasma)</measure>
    <time_frame>up to 8 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>up to 8 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t½ (terminal half-life of salmeterol in plasma)</measure>
    <time_frame>up to 8 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTih (mean residence time of salmeterol in the body after inhalational administration)</measure>
    <time_frame>up to 8 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (apparent clearance of salmeterol in the plasma after extravascular administration)</measure>
    <time_frame>up to 8 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (apparent volume of distribution during the terminal phase (λz) following an extravascular dose)</measure>
    <time_frame>up to 8 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal changes in laboratory parameters</measure>
    <time_frame>up to 14 days following the last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in vital signs</measure>
    <time_frame>up to 14 days following the last drug administration</time_frame>
    <description>Blood Pressure, Pulse Rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in 12-lead ECG parameters</measure>
    <time_frame>up to 14 days following the last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 14 days following the last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>14 days following the last drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Salmeterol capsule via Handihaler - low</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Salmeterol capsule via Handihaler - high</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Salmeterol via Serevent® Diskus®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salmeterol capsule - low</intervention_name>
    <arm_group_label>Salmeterol capsule via Handihaler - low</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salmeterol capsule - high</intervention_name>
    <arm_group_label>Salmeterol capsule via Handihaler - high</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salmeterol via Serevent® Diskus®</intervention_name>
    <arm_group_label>Salmeterol via Serevent® Diskus®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male based upon a complete medical history, including the physical&#xD;
             examination, regarding vital signs ((Blood Pressure (BP), Pulse Rate (PR)), 12-lead&#xD;
             ECG measurement, and clinical laboratory tests. There is no finding deviating from&#xD;
             normal and of clinical relevance. There is no evidence of a clinically relevant&#xD;
             concomitant disease.&#xD;
&#xD;
          2. Age ≥21 and ≤50 years&#xD;
&#xD;
          3. BMI ≥18.5 and &lt;30 kg/m2 (Body Mass Index)&#xD;
&#xD;
          4. Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice (GCP) and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any finding of the medical examination (including BP, PR, and ECG measurements)&#xD;
             deviating from normal and of clinical relevance&#xD;
&#xD;
          2. Evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          5. History of relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          6. Chronic or relevant acute infections&#xD;
&#xD;
          7. History of relevant allergy/hypersensitivity (including allergy to the drug or its&#xD;
             excipients) as judged clinically relevant by the investigator&#xD;
&#xD;
          8. Intake of drugs with a long half-life (&gt;24 hours) within at least 1 month or less than&#xD;
             10 half-lives of the respective drug prior to randomization&#xD;
&#xD;
          9. Use of drugs which might reasonably influence the results of the trial based on the&#xD;
             knowledge at the time of protocol preparation within 10 days prior to randomization&#xD;
&#xD;
         10. Participation in another trial with an investigational drug within 2 months prior to&#xD;
             randomization&#xD;
&#xD;
         11. Smoker (&gt;10 cigarettes or &gt;3 cigars or &gt;3 pipes/day)&#xD;
&#xD;
         12. Inability to refrain from smoking on trial days as judged by the investigator&#xD;
&#xD;
         13. Alcohol abuse (more than 60 g alcohol a day)&#xD;
&#xD;
         14. Drug abuse&#xD;
&#xD;
         15. Blood donation (more than 100 mL blood within 4 weeks prior to randomization or during&#xD;
             the trial)&#xD;
&#xD;
         16. Excessive physical activities within 1 week prior to randomization or during the trial&#xD;
&#xD;
         17. Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
         18. Inability to comply with dietary regimen of the study centre&#xD;
&#xD;
             The following exclusion criteria are specific for this study due to the known class&#xD;
             side effect profile of ß2-mimetics:&#xD;
&#xD;
         19. Asthma or history of pulmonary hyperreactivity&#xD;
&#xD;
         20. Hyperthyrosis&#xD;
&#xD;
         21. Allergic rhinitis in need of treatment&#xD;
&#xD;
         22. Clinically relevant cardiac arrhythmia&#xD;
&#xD;
         23. Paroxysmal tachycardia (&gt;100 beats per minute)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>September 29, 2014</last_update_submitted>
  <last_update_submitted_qc>September 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2014</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>Salmeterol Xinafoate</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/NCT02254187
org study id: 1184.17
nct id: NCT02254187
lead sponsor: 
The objective of this study is to investigate if the systemic drug exposure of at least 25 μg
      and perhaps 50 μg salmeterol presented as inhalation powder in PE capsules and administered
      via HandiHaler® 2 does not exceed that of 50 μg Serevent® Diskus® and to investigate safety
      and tolerability of salmeterol presented as inhalation powder in PE capsules and administered
      via HandiHaler® 2
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC0-∞ (area under the concentration-time curve of salmeterol in blood plasma over the time interval from 0 extrapolated to infinity)
time frame: up to 8 hours after drug administration
measure: Cmax (maximum measured concentration of salmeterol in blood plasma)
time frame: up to 8 hours after drug administration
measure: AUC0-tz (area under the concentration-time curve of salmeterol in plasma over the time interval from 0 to the time of the last quantifiable data point)
time frame: up to 8 hours after drug administration
measure: AUCt1-t2 (area under the concentration time curve of salmeterol in plasma over the time interval t1 to t2)
time frame: up to 8 hours after drug administration
measure: tmax (time from dosing to the maximum concentration of salmeterol in plasma)
time frame: up to 8 hours after drug administration
measure: λz (terminal rate constant in plasma)
time frame: up to 8 hours after drug administration
measure: t½ (terminal half-life of salmeterol in plasma)
time frame: up to 8 hours after drug administration
measure: MRTih (mean residence time of salmeterol in the body after inhalational administration)
time frame: up to 8 hours after drug administration
measure: CL/F (apparent clearance of salmeterol in the plasma after extravascular administration)
time frame: up to 8 hours after drug administration
measure: Vz/F (apparent volume of distribution during the terminal phase (λz) following an extravascular dose)
time frame: up to 8 hours after drug administration
measure: Number of patients with abnormal changes in laboratory parameters
time frame: up to 14 days following the last drug administration
measure: Number of patients with clinically significant changes in vital signs
time frame: up to 14 days following the last drug administration
description: Blood Pressure, Pulse Rate
measure: Number of patients with clinically significant changes in 12-lead ECG parameters
time frame: up to 14 days following the last drug administration
measure: Number of patients with adverse events
time frame: up to 14 days following the last drug administration
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: 14 days following the last drug administration
arm group label: Salmeterol capsule via Handihaler - low
arm group type: Experimental
arm group label: Salmeterol capsule via Handihaler - high
arm group type: Experimental
arm group label: Salmeterol via Serevent® Diskus®
arm group type: Active Comparator
intervention type: Drug
intervention name: Salmeterol capsule - low
arm group label: Salmeterol capsule via Handihaler - low
intervention type: Drug
intervention name: Salmeterol capsule - high
arm group label: Salmeterol capsule via Handihaler - high
intervention type: Drug
intervention name: Salmeterol via Serevent® Diskus®
arm group label: Salmeterol via Serevent® Diskus®
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Salmeterol Xinafoate