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Study to assess pharmacokinetics and the extend of absorption of a single dose of BIBF 1120 soft gelatine capsule with food effect (BA) in healthy subjects respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fasted administration of BIBF 1120 | Active Comparator | 150 mg of BIBF 1120 ES soft gelatine capsules in fasting state |
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| fed administration of BIBF 1120 | Experimental | three 50 mg BIBF 1120 soft gelatine capsule immediately after a high fat, high caloric meal |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBF 1120 | Drug | 150 mg of BIBF 1120 ES soft gelatine capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ (area under the concentration-time curve in plasma over time from zero time extrapolated to infinity) | Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug | |
| Cmax (maximum observed concentration in plasma) | Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| tmax (time from dosing to reach Cmax) | Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug | |
| t1/2 (terminal half-life in plasma) | Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C530716 | nintedanib |
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| MRTpo (mean residence time in the body) | Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug |
| CL/F (apparent clearance in plasma following extravascular administration) | Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug |
| Vz/F (apparent volume of distribution during the terminal phase following extravascular administration) | Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug |
| Incidence and intensity of adverse events | up to 14 days |
| Changes from baseline in vital signs (systolic and diastolic blood pressure, Pulse rate) | up to 14 days |
| Changes from baseline in laboratory tests | up to 14 days |
| Assessment of global tolerability on a 4-point scale | Day 3 of each treatment period |
| Changes from baseline in 12-lead electrocardiogram | up to 14 days |