NCT02789475Unknown1 期
DP-R212 Pharmacokinetic Study
Alvogen Korea1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2016年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- AUCτ,ss of Amlodipine and Rosuvastatin
研究概览
简要总结
An open-label, multiple-dose study to evaluate the pharmacokinetic drug-drug interaction of amlodipine and rosuvastatin in healthy adult male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •BMI 18-29
- •signed the informed consent form prior to the study participation
排除标准
- •Clinically significant disease
- •Previously donate whole blood within 60 days or component blood within 14 days
- •Clinically significant allergic disease
- •Taken IP in other trial within 90 days
- •An impossible one who participates in clinical trial by investigator's decision including laboratory test result
研究组 & 干预措施
amplodipine group
Experimental
Amlodipine for 8 days and Amlodipine+Rosuvastatin for 5 days
干预措施: Amlodipine (Drug)
amplodipine group
Experimental
Amlodipine for 8 days and Amlodipine+Rosuvastatin for 5 days
干预措施: Rosuvastatin (Drug)
rosuvastatin group
Experimental
Rosuvastatin for 5 days and Amlodipine+Rosuvastatin for 8 days
干预措施: Amlodipine (Drug)
rosuvastatin group
Experimental
Rosuvastatin for 5 days and Amlodipine+Rosuvastatin for 8 days
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
AUCτ,ss of Amlodipine and Rosuvastatin
时间窗: 0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr
Cmax,ss of Amlodipine and Rosuvastatin
时间窗: 0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr
次要结局
未报告次要终点
研究者
研究点 (1)
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