NCT02730689已完成1 期
A Randomized, Single-dose, Open, Crossover Clinical Trial to Compare the Pharmacokinetics of DP-R207 in Comparison to Each Component Administered Alone in Healthy Male Volunteers
Alvogen Korea0 个研究点目标入组 66 人开始时间: 2014年12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
- 66
- 主要终点
- Area under the plasma concentration versus time curve (AUC)
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics of DP-R207 (Rosuvastatin 10mg and Ezetimibe 10mg fixed dose combinations) in comparison to each component administered alone in health male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects age between 19 and 55 signed informed consent
排除标准
- •subjects have an allergy reaction of this drug
研究组 & 干预措施
A group
Experimental
DP-R207 >> rosuvastatin+ezetimibe
干预措施: DP-R207 (Drug)
A group
Experimental
DP-R207 >> rosuvastatin+ezetimibe
干预措施: Rosuvastatin (Drug)
A group
Experimental
DP-R207 >> rosuvastatin+ezetimibe
干预措施: Ezetimibe (Drug)
B group
Active Comparator
rosuvastatin+ezetimibe >> DP-R207
干预措施: DP-R207 (Drug)
B group
Active Comparator
rosuvastatin+ezetimibe >> DP-R207
干预措施: Rosuvastatin (Drug)
B group
Active Comparator
rosuvastatin+ezetimibe >> DP-R207
干预措施: Ezetimibe (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)
时间窗: 0-72hr
Peak Plasma Concentration (Cmax)
时间窗: 0-72hr
次要结局
未报告次要终点
研究者
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