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Trial record 63 of 729 for:    Area Under Curve AND Bioavailability

Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01306162
Recruitment Status : Completed
First Posted : March 1, 2011
Results First Posted : August 14, 2012
Last Update Posted : June 6, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE February 28, 2011
First Posted Date  ICMJE March 1, 2011
Results First Submitted Date  ICMJE May 23, 2012
Results First Posted Date  ICMJE August 14, 2012
Last Update Posted Date June 6, 2014
Study Start Date  ICMJE February 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2013)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 28, 2011)
  • AUC (area under the concentration-time curve) from time 0 to infinity of total dabigatran in plasma [ Time Frame: 0-48 hours ]
  • Cmax (maximum measured concentration) of total dabigatran in plasma [ Time Frame: 0-48 hours ]
Change History Complete list of historical versions of study NCT01306162 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2011)
  • Cmax (maximum measured concentration) of free dabigatran in plasma [ Time Frame: 0-48 hours ]
  • AUC from time 0 to infinity of free dabigatran in plasma [ Time Frame: 0-48 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2011)
36
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01306162
Other Study ID Numbers  ICMJE 1160.112
2010-024009-11 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date April 2014

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