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To investigate the relative bioavailability of BI 14332 CL vs. BI 14332 CL after intake of a standardised high fat breakfast
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 14332 CL fasted | Experimental |
| |
| BI 14332 CL fed | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 14332 CL | Drug |
| ||
| high fat breakfast |
| 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 192 hours after drug administration | |
| Cmax (maximum measured concentration of the analyte in plasma) | up to 192 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 192 hours after drug administration | |
| AUCt1-t2 (partial area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2) |
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Inclusion Criteria:
Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
Exclusion Criteria:
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| Other |
|
| up to 192 hours after drug administration |
| tmax (time from dosing to the maximum concentration of the analyte in plasma) | up to 192 hours after drug administration |
| λz (terminal rate constant in plasma) | up to 192 hours after drug administration |
| t1/2 (terminal half-life of the analyte in plasma) | up to 192 hours after drug administration |
| MRTpo (mean residence time of the analyte in the body after oral administration) | up to 192 hours after drug administration |
| CL/F (apparent clearance of the analyte in plasma after extravascular administration) | up to 192 hours after drug administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 192 hours after drug administration |
| Number of patients with adverse events | up to 23 days after last drug administration |
| Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate) | up to 23 days after last drug administration |
| Number of patients with clinically significant findings in laboratory tests | up to 23 days after last drug administration |
| Number of patients with clinically significant findings in ECG | up to 23 days after last drug administration |
| Assessment of tolerability by investigator on a 4-point scale | up to 23 days after last drug administration |