A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- AUCt(Area Under the Curve) of Fimasartan, Amlodipine and Rosuvastatin
研究概览
简要总结
A Open-label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin versus Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •a Healthy male subject, aged 19- 50 years
排除标准
- •History of clinically significant hypersensitivity to study drug, any other drug
- •Hypotension or hypertension
- •Active liver disease
- •History of gastrointestinal disease
- •History of excessive alcohol abuse
- •Participation in any other study within 3 months
研究组 & 干预措施
Group 1
Subjects of Group 1 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 1 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 15th day.
干预措施: Fimasartan/Amlodipine/Rosuvastatin (Drug)
Group 1
Subjects of Group 1 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 1 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 15th day.
干预措施: Fimasartan/Amlodipine (Drug)
Group 1
Subjects of Group 1 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 1 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 15th day.
干预措施: Rosuvastatin (Drug)
Group 2
Subjects of Group 2 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 2 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 15th day.
干预措施: Fimasartan/Amlodipine/Rosuvastatin (Drug)
Group 2
Subjects of Group 2 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 2 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 15th day.
干预措施: Fimasartan/Amlodipine (Drug)
Group 2
Subjects of Group 2 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 2 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 15th day.
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
AUCt(Area Under the Curve) of Fimasartan, Amlodipine and Rosuvastatin
时间窗: 0~144 hour after medication
Cmax of Fimasartan, Amlodipine and Rosuvastatin
时间窗: 0~144 hour after medication
次要结局
未报告次要终点