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

February 28, 2011
June 3, 2014
February 2011
May 2011   (final data collection date for primary outcome measure)
  • 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.
  • AUC (area under the concentration-time curve) from time 0 to infinity of total dabigatran in plasma [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]
  • Cmax (maximum measured concentration) of total dabigatran in plasma [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01306162 on ClinicalTrials.gov Archive Site
  • 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.
  • Cmax (maximum measured concentration) of free dabigatran in plasma [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]
  • AUC from time 0 to infinity of free dabigatran in plasma [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects
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)

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: Dabigatran etexilate plus dronedarone
    dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose
  • Drug: Dabigatran etexilate
    150 mg as single dose
  • Drug: Dabigatran etexilate plus dronedarone
    dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose (staggered administration)
  • Drug: Dabigatran etexilate plus dronedarone
    dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid
  • Drug: Dabigatran etexilate plus dronedarone
    dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid (staggered administration)
  • Experimental: A: Dabigatran alone (Reference)
    Capsule, oral administration with 240 mL water
    Intervention: Drug: Dabigatran etexilate
  • Experimental: B: Dabigatran plus Dronedarone (Test)
    Capsule and Tablets, oral administration with 240 mL water
    Intervention: Drug: Dabigatran etexilate plus dronedarone
  • Experimental: C: Dabigatran plus Dronedarone (Test)
    Capsule and Tablets, oral administration with 240 mL water
    Intervention: Drug: Dabigatran etexilate plus dronedarone
  • Experimental: D: Dabigatran plus Dronedarone (Test)
    Capsule and Tablets, oral administration with 240 mL water
    Intervention: Drug: Dabigatran etexilate plus dronedarone
  • Experimental: E: Dabigatran plus Dronedarone (Test)
    Capsule and Tablets, oral administration with 240 mL water
    Intervention: Drug: Dabigatran etexilate plus dronedarone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
Not Provided
May 2011   (final data collection date for primary outcome measure)

Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01306162
1160.112, 2010-024009-11
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP