NCT01876797

PKPD Study of Ticagrelor and Prasugrel in Healthy Korean Males

A Single Dose, Open-label, One Sequence, 2-period, Crossover Study to Characterize the Pharmacokinetics and Pharmacodynamics of Ticagrelor and Prasugrel in Healthy Male Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ticagrelor/prasugrel

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-06-13
• Last updated: 2014-03-03

Locations

1 site across 1 country: South Korea