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
Comparative pharmacokinetics of 2-4 experimental modified release formulations and oral solution of BIBV 308 SE following multiple doses, tolerability
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBV 308 SE solution | Active Comparator |
| |
| BIBV 308 SE capsule 1 | Experimental |
| |
| BIBV 308 SE capsule 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBV 308 SE solution | Drug |
| ||
| BIBV 308 SE capsule 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma at steady state (AUCss) | up to 84 hours after drug administration | |
| Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss) | up to 84 hours after drug administration | |
| Minimum measured concentration of the analyte in plasma at steady state (Cmin,ss) | up to 84 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Percent peak-trough fluctuation (%PTF) | up to 84 hours after drug administration | |
| Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss) | up to 84 hours after drug administration |
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
|
| BIBV 308 SE capsule 2 | Drug |
|
| Mean residence time of the analyte in the body (MRTtot) | up to 84 hours after drug administration |
| Apparent clearance of the analyte in plasma (CL/f) | up to 84 hours after drug administration |
| Ratio of Cmax,ss/AUCss | up to 84 hours after drug administration |
| Trough concentrations of BIBV 308 SE before doses | up to day 4 |