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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- plasma ticagrelor parent,AR-C124910XX,R-95913 and R-13727
研究概览
简要总结
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.
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Blood Sampling Times
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PK :predose,10 min,15 min,25 min, 0.5,1,1.5,2,2.5,4,6,8,12 and 24h post-dose
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PD :predose,15 min,0.5,1,2,4,6,8,12 and 24h post-dose
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Bioanalysis
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plasma Ticagrelor
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plasma AR-C124910XX (active metabolite of ticagrelor)
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plasma R-95913 (inactive metabolite of prasugrel)
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plasma R-13727 (active metabolite of prasugrel)
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Platelet Aggregation Test using turbidometric Method Maximal Platelet Aggregation(MPA)
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PK-PD Modeling analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •male aged 19 - 45 years at screening visit
- •body weight at least 60 kg at screening visit
- •body mass index 18 - 30 kg/m2
- •SBP 90 - 149 mmHg and DBP 60 - 99 mmHg and pulse rate(beat per minute) 45 - 100 at screening visit
排除标准
- •any history of or having any clinically significant abnormalities
- •any gastrointestinal disorder having impact on absorption of study drug
- •any history of hypersensitivity of ticagrelor or prasugrel or compounds related study drugs
- •any history of taking original medicines within 30 days before dosing or history of taking prescribed drug within 14 days before dosing or history of taking OTC drug within 7 days before dosing
- •any history of taking other study drug within 60 days before dosing
- •any history of whole blood transfusion within 60 days before dosing or history of blood elements transfusion or history of heaving been transfused within 30 days before 30 days
- •any history of taking metabolic inducer or inhibitor
- •overuse (caffeine: > 5 units/day , alcohol: > 21 units /week, smoking: > 10 cigarettes/day)
- •positive serology testy(Hbs antigen, HIV, Hepatitis C virus, Syphilis)
- •any abnormality in clinical laboratory tests result or any ECG finding considered to be inadequate by investigator
研究组 & 干预措施
ticagrelor-prasugrel
in period 1, 180 mg of ticagrelor will be administrated at a single oral dose. in period 2, 60 mg of prasugrel will be administrated at a single oral dose.
干预措施: ticagrelor/prasugrel (Drug)
结局指标
主要结局
plasma ticagrelor parent,AR-C124910XX,R-95913 and R-13727
时间窗: 0,10 min,15 min,25 min,0.5h,1h,1.5h,2h,2.5h,4h,6h,8h,12h and 24h
4 mL of blood will be drawn per each collection
次要结局
- Maximal Platelet Aggregation(MPA)(0,15 min,0.5 min, 1h,2h,4h,8h and 24h)
研究者
Hyeong-Seok Lim
Assistant Professor
Asan Medical Center