Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01306162
First received: February 28, 2011
Last updated: June 3, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Dabigatran etexilate plus dronedarone
Drug: Dabigatran etexilate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relative Bioavailability of a Single Dose of 150 mg Dabigatran Etexilate (Capsule) When Administered Alone or in Combination With a Single Dose of 400 mg Dronedarone Tablet) or in Combination With 400 mg Bid Dronedarone (Tablet) at Steady State in Healthy Male and Female Volunteers (an Open Label, Randomised, Four-sequence, Two Period Cross-over, Phase I Study)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Total Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity.

  • Total Dabigatran: Maximum Measured Concentration (Cmax) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Maximum measured concentration of total dabigatran in plasma, per period.


Secondary Outcome Measures:
  • Free Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Maximum measured concentration of free dabigatran in plasma, per period.


Enrollment: 36
Study Start Date: February 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: Dabigatran alone (Reference)
Capsule, oral administration with 240 mL water
Drug: Dabigatran etexilate
150 mg as single dose
Experimental: B: Dabigatran plus Dronedarone (Test)
Capsule and Tablets, oral administration with 240 mL water
Drug: Dabigatran etexilate plus dronedarone
dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose
Experimental: C: Dabigatran plus Dronedarone (Test)
Capsule and Tablets, oral administration with 240 mL water
Drug: Dabigatran etexilate plus dronedarone
dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose (staggered administration)
Experimental: D: Dabigatran plus Dronedarone (Test)
Capsule and Tablets, oral administration with 240 mL water
Drug: Dabigatran etexilate plus dronedarone
dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid
Experimental: E: Dabigatran plus Dronedarone (Test)
Capsule and Tablets, oral administration with 240 mL water
Drug: Dabigatran etexilate plus dronedarone
dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid (staggered administration)

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01306162

Locations
Germany
1160.112.1 Boehringer Ingelheim Investigational Site
Ulm, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01306162     History of Changes
Other Study ID Numbers: 1160.112, 2010-024009-11
Study First Received: February 28, 2011
Results First Received: May 23, 2012
Last Updated: June 3, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Dabigatran
Amiodarone
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on September 22, 2014