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Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01306162
First Posted: March 1, 2011
Last Update Posted: June 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  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
Intervention Model: Crossover Assignment
Masking: None (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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01306162     History of Changes
Other Study ID Numbers: 1160.112
2010-024009-11 ( EudraCT Number: EudraCT )
First Submitted: February 28, 2011
First Posted: March 1, 2011
Results First Submitted: May 23, 2012
Results First Posted: August 14, 2012
Last Update Posted: June 6, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Dabigatran
Amiodarone
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors