An Open-label, Randomized, Single Dose, 6-Sequence, 3-Period, Cross-over Study to Evaluate a Drug Interaction Between Fixed-dose Combination of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 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 interaction and safety of Fimasartan/Amlodipine and Hydrochlorothiazide 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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •A healthy Male adults aged 19-50 years
排除标准
- •History or presence of clinically significant medical or psychiatric condition or disease.
- •Hypersensitivity to ingredient of IP and other medication, food.
- •Participation in any other study within 3months.
- •History of whole blood donation within 2months and Apheresis 1month.
研究组 & 干预措施
Arm1(N=6)
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
干预措施: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide (Drug)
Arm2(N=6)
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
干预措施: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide (Drug)
Arm3(N=6)
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
干预措施: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide (Drug)
Arm4(N=6)
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
干预措施: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide (Drug)
Arm5(N=6)
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
干预措施: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide (Drug)
Arm6(N=6)
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
干预措施: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide (Drug)
结局指标
主要结局
Cmax
时间窗: 0~48hours after medication
Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma
次要结局
- AUCt(0~48hours after medication)