drugset / Trial / NCT02182193

Safety and Relative Bioavailability of BIBF 1120 Soft Gelatine Capsules Charge 1, BIBF 1120 Soft Gelatine Capsules Charge 2 and BIBF 1120 Drinking Solution in Healthy Male Volunteers

NCT02182193

Phase 1 Completed 54 enrolled Boehringer Ingelheim
Non-randomizedCrossoverOpen-labelTreatment

Summary

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)

Timeline

Start
2006-09
Primary completion
2006-11
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Nintedanib Small molecule 150 mg Oral

Indications

No indication recorded.