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Study to evaluate safety, tolerability, and pharmacokinetics of BI 1744 CL in healthy Japanese male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1744 CL | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1744 CL | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with abnormal findings in physical examination | Baseline, up to 13 days after last drug administration | |
| Number of patients with clinically relevant findings in vital signs (blood pressure, pulse rate) | Baseline, up to 13 days after last drug administration | |
| Number of patients with abnormal findings in 12-lead electrocardiogram (ECG) | Baseline, up to 13 days after last drug administration | |
| Number of patients with clinically significant changes in clinical laboratory tests | Baseline, up to 13 days after last drug administration | |
| Change from baseline in potassium level | Baseline and Day 14 | |
| Number of patients with adverse events | 7 weeks | |
| Assessment of tolerability on a 4-point scale | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum measured concentration of the analyte in plasma at different time points) | Up to day 18 | |
| tmax (time from dosing to maximum measured concentration of the analyte in plasma at different time points) | Up to day 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C549647 | olodaterol |
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| AUC (area under the concentration-time curve of the analyte in plasma at different time points) | Up to day 18 |
| %AUCtz-∞ (the percentage of the AUC 0-infinity that is obtained by extrapolation) | Up to day 18 |
| λz (terminal rate constant in plasma at different time points) | Up to day 18 |
| t1/2 (terminal half-life of the analyte in plasma at different time points) | Up to day 18 |
| MRTih (mean residence time of the analyte in the body after inhalation administration at different time points) | Up to day 18 |
| Aeτ (amount of analyte that is eliminated in urine after administration over a uniform dosing interval τ at different time points) | Up to day 18 |
| feτ (fraction of analyte eliminated in urine after administration over a uniform dosing interval τ at different time points) | Up to day 18 |
| CLR (renal clearance of the analyte at different time points) | Up to day 18 |
| Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) | Up to day 18 |
| Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose) | Up to day 18 |
| AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) | Up to day 18 |
| CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration) | Up to day 18 |
| Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration) | Up to day 18 |
| Accumulation ratio (RA,AUC) | Up to day 18 |
| Accumulation ratio (RA,Cmax) | Up to day 18 |