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PKPD Study of Ticagrelor and Prasugrel in Healthy Korean Males

Asan Medical Center · 2013
ClinicalTrials.gov · Datasets · License: Public Domain · 2013
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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
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