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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salmeterol MDI low | Experimental |
| |
| Salmeterol MDI high | Active Comparator |
| |
| Salmeterol Diskus low | Experimental |
| |
| Salmeterol Diskus high | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salmeterol Diskus low | Drug |
| ||
| Salmeterol Diskus high |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | Up to 6 hours after drug administration | |
| Cmax (maximum measured concentration of the analyte in plasma) | Up to 6 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) | Up to 6 hours after drug administration | |
| AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2) |
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Inclusion Criteria:
Healthy males according to the following criteria:
Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram) , clinical laboratory tests 1.1 No finding deviating from normal and of clinical relevance 1.2 No evidence of a clinically relevant concomitant disease
Age ≥21 and ≤50 years
BMI ≥18.5 and <30 kg/m2 (Body Mass Index)
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:
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts.
Chronic or relevant acute infections
History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
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 administration or during the trial.
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 administration or during the trial.
Participation in another trial with an investigational drug within 2 months prior to administration or during the trial.
Smoker (more than 10 cigarettes or three cigars or three pipes per day)
Inability to refrain from smoking on trial days
Alcohol abuse (more than 60 g/day)
Drug abuse
Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
Excessive physical activities (within 1 week prior to administration or during the trial)
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of study centre
Exclusion criterion specific for this study:
Asthma or history of pulmonary hyperreactivity
Allergy / hypersensitivity to Lactose monohydrate
Hyperthyrosis
Allergic rhinitis in need of treatment
Cardiac arrhythmia
Paroxysmal tachycardia (> 100 beats per minute)
Aortic stenosis
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|
| Salmeterol MDI low | Drug |
|
| Salmeterol MDI high | Drug |
|
| Up to 6 hours after inhalation |
| tmax (time from dosing to the maximum concentration of the analyte in plasma) | Up to 6 hours after drug administration |
| λz (terminal rate constant in plasma) | Up to 6 hours after drug administration |
| t½ (terminal half-life of the analyte in plasma) | Up to 6 hours after drug administration |
| MRTinh (mean residence time of the analyte in the body after inhalational administration) | Up to 6 hours after drug administration |
| CL/F (apparent clearance of the analyte in the plasma after extravascular administration) | Up to 6 hours after drug administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | Up to 6 hours after drug administration |
| Aet1-t2 (amount of analyte that was eliminated in urine from the time interval t1 to t2) | Up to 6 hours after inhalation |
| fet1-t2 (fraction of administered drug excreted unchanged in urine from time point t1 to t2) | Up to 6 hours after inhalation |
| CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 to t2) | Up to 6 hours after inhalation |
| Number of participants with abnormal findings in physical examination | Up to 15 days after last drug administration |
| Number of participants with clinically significant changes in vital signs | Up to 15 days after last drug administration |
| Number of participants with abnormal findings in ECG | Up to 15 days after last drug administration |
| Number of participants with abnormal changes in clinical laboratory parameters | Up to 15 days after last drug administration |
| Number of participants with adverse events | Up to 15 days after last drug administration |