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Aim of this trial is to investigate the single dose pharmacokinetics and the effect of food on single dose of 160 mg 245 CL (two 80 mg tablets) as well as its safety
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBX 245 CL - fed | Experimental | after a light breakfast with 40 g fat |
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| BIBX 245 CL - fasted | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBX 245 CL - fed | Drug |
| ||
| BIBX 245 CL- fasted |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum measured concentration of the analyte in plasma) | up to 24 hours post dose | |
| 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 post dose | |
| tmax (Time from dosing to the maximum concentration of the analyte in plasma) | up to 24 hours post dose | |
| λz (Terminal rate constant in plasma) | up to 24 hours post dose | |
| t½ (Terminal half-life of the analyte in plasma) | up to 24 hours post dose | |
| MRTtot (Mean residence time) | up to 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | up to 20 days | |
| Assessment of tolerability by investigator | after 20 days |
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Inclusion Criteria:
Exclusion Criteria:
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