PKPD Study of Ticagrelor and Prasugrel in Healthy Korean Males
Summary
This study is to characterize the pharmacokinetic and pharmacodynamics of ticagrelor and prasugrel in healthy Korean male subjects. The study is open label, one sequence, crossover design. In period 1, a single oral dose of 180 mg ticagrelor will be administrated. After at least 7 days washout period, in period 2, a single oral dose of 60 mg prasugrel will be administrated. After dosing each period, blood sampling for PK and PD assessment will be conducted. 1. Blood Sampling Times 1. PK :predose,10 min,15 min,25 min, 0.5,1,1.5,2,2.5,4,6,8,12 and 24h post-dose 2. PD :predose,15 min,0.5,1,2,4,6,8,12 and 24h post-dose 2. Bioanalysis 1. plasma Ticagrelor 2. plasma AR-C124910XX (active metabolite of ticagrelor) 3. plasma R-95913 (inactive metabolite of prasugrel) 4. plasma R-13727 (active metabolite of prasugrel) 3. Platelet Aggregation Test using turbidometric Method Maximal Platelet Aggregation(MPA) 4. PK-PD Modeling analysis
Timeline
- Start
- 2013-07
- Primary completion
- 2013-08
- Completion
- 2013-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prasugrel | Small molecule | 60 mg | Oral |
| Subject | Ticagrelor | Small molecule | 180 mg | Oral |
Indications
No indication recorded.