Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 34
Healthy volunteers: yes

Brief summary:
The objective of the current study is to investigate the relative bioavailability of a single dose of nintedanib low or high dose with and without coadministration of ketoconazole at steady state

Detailed description:

Arms:
arm 1: single dose, oral with 240 ml water arm 2: Nintedanib single dose, Ketoconazole steady state, oral with 240 ml water arm 3: single dose, oral with 240 ml water arm 4: Nintedanib single dose, Ketoconazole steady state, oral with 240 ml water

Interventions: intervention 1: Nintedanib intervention 2: Nintedanib intervention 3: Ketoconazole intervention 4: Nintedanib intervention 5: Nintedanib intervention 6: Ketoconazole
Intervention descriptions: intervention 1: low or medium dose depending on pilot part intervention 2: low dose oral administration intervention 3: oral administration intervention 4: low dose oral administration intervention 5: low or medium dose depending on pilot part intervention 6: oral administration

Protocol document: