NCT02058472Unknown1 期
An Open Label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety Following Administration of G3041 and SEVIKAR® Tablet in Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 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
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers between the ages of 19 to 55 years old
- •19 ≤ BMI ≤ 27
- •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 olmesartan
- •Exceed 1.5 times of the upper limit of the reference range of AST, ALT, total bilirubin, γ-GT
- •Excessive drinking(exceed alcohol 140g/week)
- •Excessive caffeine(exceed 4cups/day) and grape fruit/orange juice(exceed 1cup/day)
- •Smoking over 10 cigarettes per day
研究组 & 干预措施
G3041
Experimental
Amlodipine orotate 10mg/Olmesartan medoxomil 40mg
干预措施: G3041 (Drug)
G3041
Experimental
Amlodipine orotate 10mg/Olmesartan medoxomil 40mg
干预措施: SEVIKAR® (Drug)
SEVIKAR®
Active Comparator
Amlodipine besylate 10mg/Olmesartan medoxomil 40mg
干预措施: G3041 (Drug)
SEVIKAR®
Active Comparator
Amlodipine besylate 10mg/Olmesartan medoxomil 40mg
干预措施: SEVIKAR® (Drug)
结局指标
主要结局
AUClast, Cmax
时间窗: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h
次要结局
- ΔAUEC24, ΔEmax, tEmax(0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h)
- tmax, t1/2, AUCinf, CL/F, Vz/F(Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h)
研究者
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