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Pharmacokinetics of Salmeterol Via HandiHaler® in Healthy Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02254187
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE September 29, 2014
First Posted Date  ICMJE October 1, 2014
Last Update Posted Date October 1, 2014
Study Start Date  ICMJE September 2005
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
  • 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 ]
  • Cmax (maximum measured concentration of salmeterol in blood plasma) [ Time Frame: up to 8 hours after drug administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
  • 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 ]
  • 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 ]
  • tmax (time from dosing to the maximum concentration of salmeterol in plasma) [ Time Frame: up to 8 hours after drug administration ]
  • λz (terminal rate constant in plasma) [ Time Frame: up to 8 hours after drug administration ]
  • t½ (terminal half-life of salmeterol in plasma) [ Time Frame: up to 8 hours after drug administration ]
  • MRTih (mean residence time of salmeterol in the body after inhalational administration) [ Time Frame: up to 8 hours after drug administration ]
  • CL/F (apparent clearance of salmeterol in the plasma after extravascular administration) [ Time Frame: up to 8 hours after drug administration ]
  • Vz/F (apparent volume of distribution during the terminal phase (λz) following an extravascular dose) [ Time Frame: up to 8 hours after drug administration ]
  • Number of patients with abnormal changes in laboratory parameters [ Time Frame: up to 14 days following the last drug administration ]
  • Number of patients with clinically significant changes in vital signs [ Time Frame: up to 14 days following the last drug administration ]
    Blood Pressure, Pulse Rate
  • Number of patients with clinically significant changes in 12-lead ECG parameters [ Time Frame: up to 14 days following the last drug administration ]
  • Number of patients with adverse events [ Time Frame: up to 14 days following the last drug administration ]
  • Assessment of tolerability by investigator on a 4-point scale [ Time Frame: 14 days following the last drug administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of Salmeterol Via HandiHaler® in Healthy Male Volunteers
Official Title  ICMJE 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
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Salmeterol capsule - low
  • Drug: Salmeterol capsule - high
  • Drug: Salmeterol via Serevent® Diskus®
Study Arms  ICMJE
  • Experimental: Salmeterol capsule via Handihaler - low
    Intervention: Drug: Salmeterol capsule - low
  • Experimental: Salmeterol capsule via Handihaler - high
    Intervention: Drug: Salmeterol capsule - high
  • Active Comparator: Salmeterol via Serevent® Diskus®
    Intervention: Drug: Salmeterol via Serevent® Diskus®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2014)
30
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy male based upon a complete medical history, including the physical examination, regarding vital signs ((Blood Pressure (BP), Pulse Rate (PR)), 12-lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
  2. Age ≥21 and ≤50 years
  3. BMI ≥18.5 and <30 kg/m2 (Body Mass Index)
  4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

  1. Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
  2. Evidence of a clinically relevant concomitant disease
  3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  5. History of relevant orthostatic hypotension, fainting spells or blackouts
  6. Chronic or relevant acute infections
  7. History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
  8. Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomization
  9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to randomization
  10. Participation in another trial with an investigational drug within 2 months prior to randomization
  11. Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
  12. Inability to refrain from smoking on trial days as judged by the investigator
  13. Alcohol abuse (more than 60 g alcohol a day)
  14. Drug abuse
  15. Blood donation (more than 100 mL blood within 4 weeks prior to randomization or during the trial)
  16. Excessive physical activities within 1 week prior to randomization or during the trial
  17. Any laboratory value outside the reference range that is of clinical relevance
  18. Inability to comply with dietary regimen of the study centre

    The following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics:

  19. Asthma or history of pulmonary hyperreactivity
  20. Hyperthyrosis
  21. Allergic rhinitis in need of treatment
  22. Clinically relevant cardiac arrhythmia
  23. Paroxysmal tachycardia (>100 beats per minute)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02254187
Other Study ID Numbers  ICMJE 1184.17
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP