An Open-label, Multiple-dose, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of amlodipine10mg and candesartan32mg in Healthy Male Volunteers
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
- Part A : AUC, Cmax of Candesartan
研究概览
简要总结
Clinical trial to evalate the pharmacokinetic interactions and safety between single dose of amlodipine10mg and candesartan32mg and combiation dose amlodipine10mg with candesartan32mg 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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male, Age 20 to 45
- •Subject must be willing and able to provide written informed consent to the study.
排除标准
- •History of any significant sickness, liver system, gall bladder system, kidney, nerve system, respiratory system, blood tumor, endocrine system, urinary system, mental disease, muscloskeletal system, immunity system, the ear, nose and throat system and cardiovascular system.
- •History of any significant gastrointestinal system and surgery of gastrointestinal.
- •History of any significant hypersensitivity to amlodipine, candesartan, aspirin, antibiotic.
- •Over 10 tobaccos a day.
- •Other condition which in the opinion of the investigator preclude endrollment into the study.
研究组 & 干预措施
PartA: Candesartan, Candesartan + Amolodipine
Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally
干预措施: Candesartan32mg (Drug)
PartA: Candesartan, Candesartan + Amolodipine
Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally
干预措施: Amlodipine10mg (Drug)
PartB: Amlodipine, Amlodipine+Candesartan
Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally
干预措施: Candesartan32mg (Drug)
PartB: Amlodipine, Amlodipine+Candesartan
Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally
干预措施: Amlodipine10mg (Drug)
结局指标
主要结局
Part A : AUC, Cmax of Candesartan
时间窗: Over a 24-hour sampling period
Par B : AUC, Cmax of Amlodipine
时间窗: Over a 24-hour sampling period
次要结局
- PartA: Cmin, tmax, CL/F of Candesartan(Over a 24-hour sampling period)
- PartB: Cmin, tmax, CL/F of Amlodipine(Over a 24-hour sampling period)