Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 36
Healthy volunteers: yes

Brief summary:
The objective of the study is to assess the relative bioavailability of a single dose of dabigatran after concomitant multiple oral administration of dronedarone with the aim to investigate whether and to what extent the P-gp inhibitor dronedarone affects pharmacokinetic parameters of dabigatran when administered to healthy subjects

Detailed description:

Arms:
arm 1: Capsule, oral administration with 240 mL water arm 2: Capsule and Tablets, oral administration with 240 mL water arm 3: Capsule and Tablets, oral administration with 240 mL water arm 4: Capsule and Tablets, oral administration with 240 mL water arm 5: Capsule and Tablets, oral administration with 240 mL water

Interventions: intervention 1: Dabigatran etexilate plus dronedarone intervention 2: Dabigatran etexilate intervention 3: Dabigatran etexilate plus dronedarone intervention 4: Dabigatran etexilate plus dronedarone intervention 5: Dabigatran etexilate plus dronedarone
Intervention descriptions: intervention 1: dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose intervention 2: 150 mg as single dose intervention 3: dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose (staggered administration) intervention 4: dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid intervention 5: dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid (staggered administration)

Protocol document: