NCT01964365已完成1 期
An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Rosuvastatin and Fenofibric Acid in Healthy Adult Subjects
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年9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
- 30
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between rosuvastatin and fenofibric acid in healthy adult subjects
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
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male volunteers aged 19 to 45 years
- •A sybject who has judged to be healthy by the investigator to participate in this study based on screening result
- •A subject who provided written informed consent to participate in this study and cooperative with regared to compliance with study related constraints
排除标准
- •A subject with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history.
- •A subject who shows the following result in clinical laboratory test
- •AST, ALT > 1.25 times of the upper limit of normal range
- •PR ≥ 210 msec
- •QRS ≥ 120 msec
- •QT ≥ 500 msec
- •QTcF ≥ 500 msec
- •Subject who has taken other clinical medication from another clinical trial within 60-day period prior to the first administration of the study medication
研究组 & 干预措施
Rosuvastatin + Fenofibric acid
Experimental
multiple dose of the combination of Rosuvastatin 20mg and Fenofibric acid 135mg
干预措施: Cresto 20mg, Fenofibric acid 135mg (Drug)
Rosuvastatin
Experimental
multiple dose of Rosuvastatin 20mg
干预措施: Cresto 20mg (Drug)
Fenofibric acid
Experimental
multiple dose of Fenofibric acid 135mg
干预措施: Fenofibric acid 135mg (Drug)
结局指标
主要结局
Cmax
时间窗: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
AUCtau
时间窗: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
次要结局
- Cmin(Multiple blood sample will be collected for 24 hours after last dosing in each of the periods)
- Tmax(Multiple blood sample will be collected for 24 hours after last dosing in each of the periods)
- CL/F(Multiple blood sample will be collected for 24 hours after last dosing in each of the periods)
- T1/2(Multiple blood sample will be collected for 24 hours after last dosing in each of the periods)
- Metabolic Ratio(Multiple blood sample will be collected for 24 hours after last dosing in each of the periods)
研究者
研究点 (1)
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