Phase 1 Study of Compare the Safety, Pharmacokinetic Profiles of UI15AML055MT and Amosartan® Tablet 5/50 mg
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- AUClast of Amlodipine
研究概览
简要总结
A randomized, open-label, single dose, two-way crossover clinical trial to compare the safety, pharmacokinetic profiles of UI15AML055MT and Amosartan® tablet 5/50 mg after a single oral administration in healthy male volunteers
详细描述
A randomized, open-label, single dose, two-way crossover clinical trial to compare the safety, pharmacokinetic profiles of UI15AML055MT and Amosartan® tablet 5/50 mg after a single oral administration 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
- •Patients over 20 under 45 years of age
- •BMI state over 19 under 27
排除标准
- •mean sit SBP≥100mmHg or mean sit DBP≥150mmHg at screening
- •mean sit SBP≥65mmHg or mean sit DBP≥95mmHg at screening
- •Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST)
- •History of alcohol or drug abuse
- •Positive to pregnancy test, nursing mother, has an intention on pregnancy
- •Considered by investigator as not appropriate to participate in the clinical study with othe reason
研究组 & 干预措施
Amosartan 5/50 tab
Amosartan 5/50 tab given by oral administration
干预措施: Amosartan 5/50 (Drug)
UI15AML055MT tab
UI15AML055MT tab given by oral administration
干预措施: UI15AML055MT (Drug)
结局指标
主要结局
AUClast of Amlodipine
时间窗: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose
AUClast of Losartan
时间窗: 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose
Cmax of Amlodipine
时间窗: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose
AUCinf of Losartan
时间窗: 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose
Cmax of Losartan
时间窗: 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose
AUCinf of Amlodipine
时间窗: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose
次要结局
- Tmax of Amlodipine(1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose)
- t1/2 of Amlodipine(1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose)
- CL/F of Amlodipine(1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose)
- t1/2 of Losartan(1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose)
- CL/F of Losartan(1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose)
- Tmax of Losartan(1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose)