An Open-label, Randomized, Single-dose Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Amlodipine/Losartan and Rosuvastatin in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 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 drug-drug interaction between amlodipine/losartan and rosuvastatin in healthy 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
- Treatment
- 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
- •Age between 19 and 55
- •Signed informed consent
排除标准
- •Presence of medical history or a concurrent disease
- •Has a history of hypersensitivity to IP ingredients
研究组 & 干预措施
Sequence 1
amosartan → rosuvastatin → amosartan and rosuvastatin
干预措施: rosuvastatin (Drug)
Sequence 3
amosartan and rosuvastatin → amosartan → rosuvastatin
干预措施: amosartan (Drug)
Sequence 1
amosartan → rosuvastatin → amosartan and rosuvastatin
干预措施: amosartan (Drug)
Sequence 1
amosartan → rosuvastatin → amosartan and rosuvastatin
干预措施: amosartan and rosuvastatin (Drug)
Sequence 2
rosuvastatin → amosartan and rosuvastatin → amosartan
干预措施: amosartan (Drug)
Sequence 2
rosuvastatin → amosartan and rosuvastatin → amosartan
干预措施: rosuvastatin (Drug)
Sequence 2
rosuvastatin → amosartan and rosuvastatin → amosartan
干预措施: amosartan and rosuvastatin (Drug)
Sequence 3
amosartan and rosuvastatin → amosartan → rosuvastatin
干预措施: rosuvastatin (Drug)
Sequence 3
amosartan and rosuvastatin → amosartan → rosuvastatin
干预措施: amosartan and rosuvastatin (Drug)
结局指标
主要结局
Cmax
时间窗: 0-72h
AUClast
时间窗: 0-72h
次要结局
- AUCinf(0-72h)
- tmax(0-72h)
- t1/2(0-72h)