A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interactions and Safety Between Telmisartan and Chlorthalidone in Healthy Male Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Part A : AUC, Cmax of Telmisartan
研究概览
简要总结
Clinical trial to evaluate the pharmacokinetic interactions and safety between telmisartan and chlorthalidone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects
- •Age(yr)between 20 and 50
- •Signed written informed consent
排除标准
- •Known hypersensitivity to investigator product, thiazide, sulphonamide and other drugs or additive.
- •History of any siginificant Sickness, Cardiovascular, Respiratory, Renal, Endocrine, Neurological, Psychic, Cancer, Gasstrointestinal, Hematologic.
- •History of drug and/or alcohol abuse
- •Over 10 tobaccos a day
- •Other condition which in the opinion of the investigator preclude enrollment into the study
研究组 & 干预措施
Part A: Telmisartan, Chlorthalidone + Telmisartan
telmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally
干预措施: Telmisartan 80mg (Drug)
Part A: Telmisartan, Chlorthalidone + Telmisartan
telmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally
干预措施: Chlorthalidone 25mg (Drug)
Part B: Chlorthalidone, Chlorthalidone + Telmisartan
telmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally
干预措施: Telmisartan 80mg (Drug)
Part B: Chlorthalidone, Chlorthalidone + Telmisartan
telmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally
干预措施: Chlorthalidone 25mg (Drug)
结局指标
主要结局
Part A : AUC, Cmax of Telmisartan
时间窗: Over a 24-hour sampling period
Part B : AUC, Cmax of Chlorthalidone
时间窗: Over a 24-hour sampling period
次要结局
- Part A : Cmin, tmax, CL/F of Telmisartan(Over a 24-hour sampling period)
- Part B : Cmin, tmax, CL/F of Chlorthalidone(Over a 24-hour sampling period)