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The primary objective of this study was to compare the systemic exposure of BI 1744 BS and CD 1857 XX (the active metabolite of the pro-drug BI 54903 XX) at steady state following inhalation of the fixed dose combination (FDC) BI 1744 CL plus BI 54903 XX (as ethanolic solution for inhalation, EIS) with the systemic exposure following inhalation of the free dose combination of BI 1744 CL (as aqueous solution for inhalation, AIS) and BI 54903 XX (EIS), respectively, when administered once-daily via Respimat® Inhaler (Respimat® A for AIS and Respimat® B for EIS) for 14 days in healthy volunteers. Secondary objectives were: to compare exposure to BI 1744 BS and CD 1857 XX after a single dose of the BI 1744 CL/BI 54903 XX FDC and the free dose combination, respectively; to compare exposure to BI 54903 XX after a single dose and at steady state after multiple doses of the BI 1744 CL/BI 54903 XX fixed dose combination and the free dose combination, respectively; to compare the safety and tolerability of BI 1744 CL and BI 54903 XX when administered as BI 1744 CL/BI 54903 XX fixed dose combination and as the free dose combination, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Free dose combination | Active Comparator |
| |
| Fixed dose combination | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1744 CL | Drug |
| ||
| BI 54903 XX |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t,ss (area under the concentration time curve of the analyte in plasma from 0 to time t at steady state) | up to 24 hours after drug administration | |
| Cmax (maximum measured concentration of the analyte in plasma) | up to 24 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t,ss (area under the concentration time curve of the analyte in plasma from 0 to time t at steady state) | up to 24 hours after drug administration | |
| Cpre (pre-dose concentration of the analyte in plasma) | immediately before drug administration |
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Inclusion Criteria:
Exclusion Criteria:
For female Subjects:
Exclusion criteria specific for this study due to the known class side effect profile of ß2-mimetics and inhaled corticosteroids:
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|
| BI 1744 CL + BI 54903 XX FDC | Drug |
|
| Placebo | Drug |
|
| AUCt1-t2 (area under the concentration time curve of the analyte in plasma over the time interval t1 to t2) | up to 24 hours after drug administration |
| AUC0-t (area under the concentration time curve of the analyte in plasma from 0 to time t) | up to 24 hours after drug administration |
| 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 24 hours after drug administration |
| AUCτ (area under the plasma concentration-time curve over a uniform dosing interval τ) | up to 24 hours after drug administration |
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 24 hours after drug administration |
| %AUCtz-∞(the percentage of the AUC0-∞that is obtained by extrapolation) | up to 24 hours after drug administration |
| tmax (time from dosing to the maximum concentration of the analyte in plasma) | up to 24 hours after drug administration |
| λz (terminal rate constant of the analyte in plasma) | up to 24 hours after drug administration |
| t½ (terminal half-life of the analyte in plasma) | up to 24 hours after drug administration |
| MRTih (mean residence time of the analyte in the body after inhaled administration) | up to 24 hours after drug administration |
| CL/F (apparent clearance of the analyte in the plasma after extravascular administration) | up to 24 hours after drug administration |
| Vz/F (apparent volume of distribution of the analyte during the terminal phase following an extravascular dose) | up to 24 hours after drug administration |
| ID | Term |
|---|---|
| C549647 | olodaterol |
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