An Open-label, Randomized, Single-dose, 2X3X3 Partial Replicate, Crossover Study to Compare the Pharmacokinetics and Safety Between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Cmax (Maximum concentration of drug in plasma) of Fimasartan, Amlodipine and Rosuvastatin
研究概览
简要总结
An open-label, randomized, single-dose, 2X3X3 partial replicate, crossover study to compare the pharmacokinetics and safety between a fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin and 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
- •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
1
A fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin
干预措施: Fimasartan/Amlodipine combination drug, Rosuvastatin (Drug)
2
Co-administration of Fimasartan/Amlodipine combination drug and Rosuvastatin
干预措施: Fimasartan/Amlodipine combination drug, Rosuvastatin (Drug)
结局指标
主要结局
Cmax (Maximum concentration of drug in plasma) of Fimasartan, Amlodipine and Rosuvastatin
时间窗: 0~72 hour after medication
AUCt (Area Under the Curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine and Rosuvastatin
时间窗: 0~72 hour after medication
次要结局
未报告次要终点