Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Dabigatran etexilate; Drug: Dabigatran etexilate plus dronedarone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01306162

1160.112

2010-024009-11 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male and female subjects

Exclusion criteria

1. Any relevant deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 5 patient groups

A: Dabigatran alone (Reference)

Experimental group

Description:

Capsule, oral administration with 240 mL water

Treatment:

Drug: Dabigatran etexilate

B: Dabigatran plus Dronedarone (Test)

Experimental group

Description:

Capsule and Tablets, oral administration with 240 mL water

Treatment:

Drug: Dabigatran etexilate plus dronedarone

Drug: Dabigatran etexilate plus dronedarone

Drug: Dabigatran etexilate plus dronedarone

Drug: Dabigatran etexilate plus dronedarone

C: Dabigatran plus Dronedarone (Test)

Experimental group

Description:

Capsule and Tablets, oral administration with 240 mL water

Treatment:

Drug: Dabigatran etexilate plus dronedarone

Drug: Dabigatran etexilate plus dronedarone

Drug: Dabigatran etexilate plus dronedarone

Drug: Dabigatran etexilate plus dronedarone

D: Dabigatran plus Dronedarone (Test)

Experimental group

Description:

Capsule and Tablets, oral administration with 240 mL water

Treatment:

Drug: Dabigatran etexilate plus dronedarone

Drug: Dabigatran etexilate plus dronedarone

Drug: Dabigatran etexilate plus dronedarone

Drug: Dabigatran etexilate plus dronedarone

E: Dabigatran plus Dronedarone (Test)

Experimental group

Description:

Capsule and Tablets, oral administration with 240 mL water

Treatment:

Drug: Dabigatran etexilate plus dronedarone

Drug: Dabigatran etexilate plus dronedarone

Drug: Dabigatran etexilate plus dronedarone

Drug: Dabigatran etexilate plus dronedarone