Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 70
Healthy volunteers: yes

Brief summary:
To establish the bioequivalence of 1 soft gelatine capsule containing 200 mg nintedanib compared to 2 soft gelatine capsules containing 100 mg nintedanib

Detailed description:

Arms:
arm 1: Nintedanib, 1 capsule, oral with 240 mL of water arm 2: Nintedanib, 2 capsules, oral with 240 mL of water arm 3: Nintedanib, 2 capsules, oral with 240 mL of water

Interventions: intervention 1: Nintedanib intervention 2: Nintedanib intervention 3: Nintedanib
Intervention descriptions: intervention 1: 1 soft gelatine capsule, single dose, oral intervention 2: Nintedanib, 2 soft gelatine capsules, single dose, oral intervention 3: None

Protocol document: