Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of the present study is to investigate the relative bioavailability of BIIL 284 BS Tablet FF in comparison to the tablet C at a dose of 5 mg after a standard breakfast in healthy male volunteers
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIL 284 BS Tablet FF | Experimental |
| |
| BIIL 284 BS tablet C | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIL 284 BS Tablet FF | Drug |
| ||
| BIIL 284 BS tablet C |
| 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 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-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) | up to 24 hours after drug administration | |
| tmax (Time from dosing to the maximum concentration of the analyte in plasma) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| standard breakfast | Other |
|
| up to 24 hours after drug administration |
| Terminal rate constant 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 |
| MRTtot (total mean residence time) | up to 24 hours after drug administration |
| CL/F (Apparent clearance of the analyte in plasma following extravascular administration) | up to 24 hours after drug administration |
| Vz/F (Apparent volume of distribution of the analyte during the terminal phase) | up to 24 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 |