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The objective of the present study is to investigate the relative bioavailability of BIIL 284 BS boli in comparison to the tablet C at a dose of 75 mg in fasted condition and after a standard breakfast in healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIL 284 BS boli - fasted | Experimental |
| |
| BIIL 284 BS boli - fed | Experimental |
| |
| BIIL 284 BS tablet C - fasted | Active Comparator |
| |
| BIIL 284 BS tablet C - fed | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIL 284 BS boli | Drug |
| ||
| BIIL 284 BS tablet C |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels of BIIL 315 ZW | up to 72 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 72 hours after drug administration | |
| Cmax (Maximum measured concentration of the analyte in plasma) | up to 72 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| tmax (Time from dosing to the maximum concentration of the analyte in plasma) | up to 72 hours after drug administration | |
| t½ (Terminal half-life of the analyte in plasma) | up to 72 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| standard breakfast | Other |
|
| MRTtot (Total mean residence time) | up to 72 hours after drug administration |
| Vz/F (Apparent volume of distribution of the analyte during the terminal phase) | up to 72 hours after drug administration |
| CLtot/F (Total clearance after oral administration) | up to 72 hours after drug administration |
| Number of subjects with adverse events | up to 8 days after last drug administration |
| Number of subjects with clinically significant findings in vital functions | blood pressure, pulse rate, ECG | up to 8 days after last drug administration |
| Number of subjects with clinically significant findings in laboratory tests | up to 8 days after last drug administration |