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To assess pharmacokinetics and the relative bioavailability of a single dose of BIBF 1120 soft gelatine capsule charge 1 vs. BIBF 1120 soft gelatine capsule charge 2 vs BIBF 1120 drinking solution in healthy male subjects respectively. To establish an in-vitro-in-vivo correlation (IVIVC) for oral soft gelatine capsules with 150 mg BIBF 1120 in healthy male volunteers (if feasible)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBF 1120 capsules charge 1 | Experimental |
| |
| BIBF 1120 capsules charge 2 | Experimental |
| |
| BIBF 1120 drinking solution | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBF 1120 capsules charge 1 | Drug |
| ||
| BIBF 1120 capsules charge 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve of the analyte from zero time (pre-dose) extrapolated to infinity (AUC0-∞) | 1 h pre dose and up to 48 h after drug administration | |
| Individual maximum observed concentrations of the analyte in plasma (Cmax) | 1 h pre dose and up to 48 h after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve of the analyte over the time interval from time zero (pre-dose) to 24 hours (AUC0-24) | 1 h pre dose and up to 24 h after drug administration | |
| time from dosing to the maximum concentration of the analyte in plasma (tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| BIBF 1120 drinking solution | Drug |
|
| 1 h pre dose and up to 48 h after drug administration |
| Terminal rate constant in plasma (λz) | 1 h pre dose and up to 48 h after drug administration |
| Terminal half-life of the analyte in plasma (t1/2) | 1 h pre dose and up to 48 h after drug administration |
| Mean residence time of the analyte in the body after oral administration (MRTpo) | 1 h pre dose and up to 48 h after drug administration |
| Apparent clearance of the analyte in the plasma after extravascular administration (CL/F) | 1 h pre dose and up to 48 h after drug administration |
| Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) | 1 h pre dose and up to 48 h after drug administration |
| Change in vital signs (blood pressure, pulse rate) | Baseline, up to 24 hours after drug administration |
| Change in routine laboratory values | pre-dose, up to 48 hours after drug administration |
| Change in ECG | pre-dose, 4 hours after drug administration, day 32 |
| Occurrence of adverse events | up to 32 days after drug administration |
| Assessment of tolerability by investigator on a 4 point scale | 48 hours after drug administration |