A Randomized, Open-label, Single Dose, 3-Treatment, 3-Period Williams-Design to Assess the Pharmacokinetic Characteristics and Food Effect of Sarpogrelate HCl CR Tablets Compared With Sarpogrelate HCl IR Tablets in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Cmax
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics of sarpogrelate controlled-release formulation (CR) in comparison to immediate-release formulation (IR) and Food effect on the pharmacokinetics of sarpogrelate CR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •20 to 55 years of healthy volunteers
排除标准
- •Hypersensitivity Reaction about Sarpogrelate HCl or other antiplatelets
研究组 & 干预措施
Anplag
Sarpogrelate HCl 300mg once a day or 100mg three times a day
干预措施: Anplag (Drug)
Anplag
Sarpogrelate HCl 300mg once a day or 100mg three times a day
干预措施: UI03SPG300CT (Drug)
UI03SPG300CT
Sarpogrelate HCl 300mg once a day or 100mg three times a day
干预措施: Anplag (Drug)
UI03SPG300CT
Sarpogrelate HCl 300mg once a day or 100mg three times a day
干预措施: UI03SPG300CT (Drug)
结局指标
主要结局
Cmax
时间窗: 24h
Active Comparator : predose(0), 0.25, 0.5, 1, 1.5, 2, 3, 6(immediately before 2nd drug intake) , 6.25, 6.5, 7, 7.5, 8, 9, 12(immediately before 3rd drug intake), 12.5, 13, 13.5, 14, 15, 16, 24 hours post-dose Experimental : predose(0), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 hours post-dose
AUCt
时间窗: 24h
Active Comparator : predose(0), 0.25, 0.5, 1, 1.5, 2, 3, 6(immediately before 2nd drug intake) , 6.25, 6.5, 7, 7.5, 8, 9,12(immediately before 3rd drug intake), 12.5, 13, 13.5, 14, 15, 16, 24 hours post-dose Experimental : predose(0), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 hours post-dose
次要结局
- tmax, t1/2(24h)
- AUC0-∞(24h)