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Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01734772
First received: November 15, 2012
Last updated: April 2, 2014
Last verified: April 2014

November 15, 2012
April 2, 2014
November 2012
June 2013   (final data collection date for primary outcome measure)
  • Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss) [ Time Frame: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours ] [ Designated as safety issue: No ]
    Area under the concentration-time curve of dabigatran etexilate in plasma at steady state over the uniform dosing interval τ (AUCτ,ss).
  • Total Dabigatran: Maximum Measured Concentration at Steady State (Cmax,ss) [ Time Frame: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours ] [ Designated as safety issue: No ]
    Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).
  • pharmacokinetic interaction (AUCt,ss of dabigatran [Area under the curve over the dosing interval t under steady state conditions]) [ Time Frame: up to 12 hours ] [ Designated as safety issue: No ]
  • pharmacokinetic interaction (Cmax,ss of dabigatran [maximum measured concentration over the uniform dosing interval under steady state conditions]) [ Time Frame: up to 12 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01734772 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor
Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor Under Steady State Conditions in Healthy Male Subjects

To investigate the pharmacokinetic and pharmacodynamic interaction of dabigatran and ticagrelor under steady state conditions; to investigate the effect of staggered administration of ticagrelor loading dose on dabigatran exposure (in Part II)

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: dabigatran etexilate
    multiple doses of dabigatran
  • Drug: dabigatran etexilate
    medium dose dabigatran
  • Drug: ticagrelor
    loading dose of ticagrelor
  • Drug: ticagrelor
    multiple doses of ticagrelor
  • Drug: dabigatran etexilate
    single dose of dabigatran
  • Experimental: Reference (Part 1/A, Part 2/C)
    multiple doses of dabigatran (alone)
    Intervention: Drug: dabigatran etexilate
  • Experimental: Test 1 (Part 1/Treatment B)
    concomitant administration of dabigatran and ticagrelor
    Interventions:
    • Drug: dabigatran etexilate
    • Drug: ticagrelor
    • Drug: ticagrelor
  • Experimental: Test 2 (Part 2/Treatment D)
    staggered administration of ticagrelor and dabigatran
    Interventions:
    • Drug: ticagrelor
    • Drug: dabigatran etexilate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

1. Healthy male subjects.

Exclusion criteria:

1. Any relevant deviation from healthy conditions.

Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01734772
1160.142, 2012-002656-16
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