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Comparative pharmacokinetics and tolerability of two experimental extended release formulations and a standard formulation of BIBV 308 SE following multiple doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBV 308 SE solution | Active Comparator |
| |
| BIBV 308 SE capsule L | Experimental |
| |
| BIBV 308 SE capsule S | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBV 308 SE solution | Drug |
| ||
| BIBV 308 SE capsule L |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma at steady state (AUCss) | up to 84 hours | |
| Maximum plasma concentration at steady state (Cmax,ss) | up to 84 hours | |
| Minimum plasma concentration at steady state (Cmin,ss) | up to 84 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percent peak-to-trough fluctuation (%PTF) | up to 84 hours | |
| Time to maximum plasma concentration in steady state (tmax,ss) | up to 84 hours | |
| Mean residence time in steady state (MRT,ss) |
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Inclusion Criteria:
Exclusion Criteria:
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|
| BIBV 308 SE capsule S | Drug |
|
| up to 84 hours |
| Total plasma clearance (CL/f) | up to 84 hours |
| Quotient of Cmax,ss and AUCss (Cmax,ss/AUCss) | up to 84 hours |
| Number of patients with adverse events | up to 5 days after last drug administration |
| Number of patients with clinically significant findings in vital signs | pulse rate, blood pressure | up to 5 days after last drug administration |
| Number of patients with clinically significant findings in laboratory tests | up to 5 days after last drug administration |
| Trough concentration of BIBV 308 SE before doses | up to 84 hours |