Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Dabigatran etexilate; Drug: Dabigatran etexilate plus dronedarone

• Registration Number: NCT01306162
• Lead Sponsor: Boehringer Ingelheim

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

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-28
• Study First Submitted QC: 2011-02-28
• Study First Posted: 2011-03-01
• Primary Completion: 2011-05
• Results First Submitted: 2012-05-23
• Results First Submitted QC: 2012-06-29
• Results First Posted: 2012-08-14
• Status Verified: 2014-04
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A: Dabigatran alone (Reference)	Dabigatran etexilate	Capsule, oral administration with 240 mL water
C: Dabigatran plus Dronedarone (Test)	Dabigatran etexilate plus dronedarone	Capsule and Tablets, oral administration with 240 mL water
B: Dabigatran plus Dronedarone (Test)	Dabigatran etexilate plus dronedarone	Capsule and Tablets, oral administration with 240 mL water
D: Dabigatran plus Dronedarone (Test)	Dabigatran etexilate plus dronedarone	Capsule and Tablets, oral administration with 240 mL water
E: Dabigatran plus Dronedarone (Test)	Dabigatran etexilate plus dronedarone	Capsule and Tablets, oral administration with 240 mL water

Primary Outcome Measures

Name	Time	Method
Total Dabigatran: Maximum Measured Concentration (Cmax)	1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration	Maximum measured concentration of total dabigatran in plasma, per period.
Total Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)	1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration	Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity.

Secondary Outcome Measures

Name	Time	Method
Free Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)	1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration	Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity.
Free Dabigatran: Maximum Measured Concentration (Cmax)	1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration	Maximum measured concentration of free dabigatran in plasma, per period.

Trial Locations

Locations (1)

1160.112.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Ulm, Germany