Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor and Assessment of Ticagrelor Interaction Potential With Dabigatran
- Registration Number
- NCT01595854
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new pharmacodynamic methods
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Test 2 (part 3) Ticagrelor low dose dabigatran + high dose ticagrelor Test 2 (part 3) dabigatran etexilate low dose dabigatran + high dose ticagrelor Test 1 (part 1 + 2) Ticagrelor high dose ticagrelor Reference 1 (part 1 + 2) dabigatran etexilate medium dose dabigatran Reference 2 (part 3) dabigatran etexilate low dose dabigatran
- Primary Outcome Measures
Name Time Method Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞) -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours Area under the concentration-time curve of the analyte in plasma, over the time interval from 0 extrapolated to infinity, of dabigatran.
Total Dabigatran: Maximum Measured Concentration (Cmax) -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours Maximum measured concentration of total dabigatran in plasma, per period.
- Secondary Outcome Measures
Name Time Method Number of Participants With Drug Related Adverse Events From screening until the end-of-study examination The number of participants with drug related adverse events
Trial Locations
- Locations (1)
1160.141.1 Boehringer Ingelheim Investigational Site
🇩🇪Biberach, Germany