NCT01421576已完成1 期
A Randomized, Single-dose, 2-sequence, 2-period Crossover Study to Investigate the Food-effect Pharmacokinetics of Sarpogrelate HCl Controlled Release Tablet in Healthy Male Subjects
Alvogen Korea2 个研究点 分布在 2 个国家目标入组 24 人开始时间: 2011年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Composite of Pharmacokinetics(Cmax, AUClast)
研究概览
简要总结
A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect on the pharmacokinetics of DP-R202 tablet after oral administration in healthy male volunteers.
详细描述
The number of patient is twenty-four.Patients were randomly assigned either DP-R202(Sarpogrelate HCL 300mg, qd) under fasting condition or DP-R202(Sarpogrelate HCL 300mg, qd) after eating foods.
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
High fat meal
Active Comparator
干预措施: High fat meal (Dietary Supplement)
DP-R202
Experimental
under fed condition
干预措施: High fat meal (Dietary Supplement)
结局指标
主要结局
Composite of Pharmacokinetics(Cmax, AUClast)
时间窗: 24h
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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