Healthy
Conditions
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
Interventions
DRUGSalmeterol capsule - low
DRUGSalmeterol capsule - high
DRUGSalmeterol via Serevent® Diskus®
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-∞ (area under the concentration-time curve of salmeterol in blood plasma over the time interval from 0 extrapolated to infinity) | up to 8 hours after drug administration |
| Cmax (maximum measured concentration of salmeterol in blood plasma) | up to 8 hours after drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events | up to 14 days following the last drug administration | — |
| 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) | 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) | up to 8 hours after drug administration | — |
| tmax (time from dosing to the maximum concentration of salmeterol in plasma) | up to 8 hours after drug administration | — |
| λz (terminal rate constant in plasma) | up to 8 hours after drug administration | — |
| Assessment of tolerability by investigator on a 4-point scale | 14 days following the last drug administration | — |
| MRTih (mean residence time of salmeterol in the body after inhalational administration) | up to 8 hours after drug administration | — |
| CL/F (apparent clearance of salmeterol in the plasma after extravascular administration) | up to 8 hours after drug administration | — |
| Vz/F (apparent volume of distribution during the terminal phase (λz) following an extravascular dose) | up to 8 hours after drug administration | — |
| Number of patients with abnormal changes in laboratory parameters | up to 14 days following the last drug administration | — |
| Number of patients with clinically significant changes in vital signs | up to 14 days following the last drug administration | Blood Pressure, Pulse Rate |
| t½ (terminal half-life of salmeterol in plasma) | up to 8 hours after drug administration | — |
| Number of patients with clinically significant changes in 12-lead ECG parameters | up to 14 days following the last drug administration | — |
Outcome results
None listed