A Randomized, Open-label, Single Dose, Replicate Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Cmax of Telmisartan/amlodipine/chlorthalidone
研究概览
简要总结
This is a phase 1, randomized, open label, single-dose, replicate crossover clinical trial to compare the safety and pharmacokinetics of YH22162 in healthy male volunteers.
Hypothesis: Study drug and comparator drug are showing equal pharmacokinetics.
详细描述
In ARM1, 32 subjects will be assigned and the subjects will be administered "comparator drug" at Day1/Day43 and "study drug" at Day22/64.
In ARM2, 32 subjects will be assigned and the subjects will be administered "study drug" at Day1/Day43 and "comparator drug" at Day22/64.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
- •Who has not suffered from clinically significant disease
- •Provision of signed written informed consent
排除标准
- •History of and clinically significant disease
- •Administration of other investigational products within 3 months prior to the first dosing
- •Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs
研究组 & 干预措施
ARM1
In ARM1, 32 subjects will be assigned and the subjects will be administered "comparator drug" at Day1/Day43 and "study drug" at Day22/64.
干预措施: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg (Drug)
ARM2
In ARM2, 32 subjects will be assigned and the subjects will be administered "study drug" at Day1/Day43 and "comparator drug" at Day22/64.
干预措施: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg (Drug)
结局指标
主要结局
Cmax of Telmisartan/amlodipine/chlorthalidone
时间窗: 0-168 hrs
Cmax
AUClast of Telmisartan/amlodipine/chlorthalidone
时间窗: 0-168 hrs
AUClast
次要结局
- t1/2 of Telmisartan/amlodipine/chlorthalidone(0-168 hrs)
- AUCinf of Telmisartan/amlodipine/chlorthalidone(0-168 hrs)
- Tmax of Telmisartan/amlodipine/chlorthalidone(0-168 hrs)