NCT01776047已完成1 期
A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- AUClast, Cmax
研究概览
简要总结
Study Design : randomized, open label, single-dose, 2-way cross-over design
Phase : Phase I
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male volunteers between the ages of 20 to 50 years old within the range of ±20% of IBW(Ideal Body Weight)
- •having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
- •doctor determines to be suitable as subjects within 4 weeks ago before administration
排除标准
- •Hypersensitivity(or history of hypersensitivity) to amlodipine and valsartan
- •Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT
- •Gastrointestinal diseases or surgeries that affect absorption of drug
- •Excessive drinking(exceed 30g/week) and excessive caffeine(exceed 250mg/day)
- •Smoking over 10 cigarettes per day
研究组 & 干预措施
Exforge® 10/160 (Amlodipine besylate 10mg / Valsartan 160mg)
Active Comparator
Exforge® 10/160
干预措施: Exforge® (Drug)
G-0081 (Amlodipine orotate 10mg / Valsratan 160mg)
Experimental
G-0081
干预措施: G-0081 (Drug)
结局指标
主要结局
AUClast, Cmax
时间窗: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h
次要结局
- AUCinf, Tmax, t1/2, % AUCextra(Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h)
研究者
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