NCT02289430已完成1 期
A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers
NVP Healthcare0 个研究点目标入组 59 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
- 59
- 主要终点
- Area Under Curve
研究概览
简要总结
The purpose of this study is to compare the drug interaction of pharmacokinetics of rosuvastatin and ezetimibe.
详细描述
drug interaction : rosuvastatin, ezetimibe
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
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects age between 19 and 45 singed informed consent
排除标准
- •Hypotension or hypertension has a history of allergy reaction of this drug or other drugs
研究组 & 干预措施
Crestor+Ezetrol
Experimental
rosuvastatin+ezetimibe
干预措施: Crestor+Ezetrol (Drug)
Ezetrol
Active Comparator
ezetimibe
干预措施: Ezetrol (Drug)
Crestor
Active Comparator
rosuvastatin
干预措施: Crestor (Drug)
结局指标
主要结局
Area Under Curve
时间窗: 0-24h
次要结局
未报告次要终点
研究者
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