NCT01421563已完成1 期
A Randomized, Open-label, Two-Sequence, Two-Period Crossover Study to Assess the Pharmacokinetic Characteristics of Sarpogrelate HCl Controlled Release Tablet Compared With Sarpogrelate HCl Immediate Release Tablet in Healthy Male Subjects
Alvogen Korea1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Cmax, AUClast
研究概览
简要总结
The purpose of this study is compare the safety and pharmacokinetic characteristics of DP-R202 (Sarpogrelate HCl 300mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid) after oral administration in healthy male volunteers.
详细描述
The number of patient is thirthy-six.Patients were randomly assigned either anplag tablet(Sarpogrelate HCL 100mg, tid)first, DP-R202(Sarpogrelate HCL 300mg, qd) Second or DP-R202(Sarpogrelate HCL 300mg, qd) first, anplag tablet(Sarpogrelate HCL 100mg, tid) second.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
Active Comparator
干预措施: Anplag (Drug)
DP-R202
Experimental
干预措施: Anplag (Drug)
结局指标
主要结局
Cmax, AUClast
时间窗: 24h
次要结局
- tmax, t1/2, AUC0-∞(24h)
研究者
研究点 (1)
Loading locations...
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