NCT02387554已完成1 期
A Randomized, Open-label, 4-way Crossover Single Dose Clinical Trial to Investigate the Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405 When Administered Alone and in Combination in Healthy Male Volunteers
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- AUClast
研究概览
简要总结
The purpose of this study is to investigate the pharmacokinetic interaction and safety between HGP0904, HGP0608 and HGP1405 when administered alone and in combination 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
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •19~45 years old
- •Healthy men
排除标准
- •Gastroentestinal disease affecting drug absorption
研究组 & 干预措施
HGP0904+HGP0608+HGP1405
Experimental
amlodipine + losartan + chlorthalidone
干预措施: HGP0904 (Drug)
HGP0904+HGP0608+HGP1405
Experimental
amlodipine + losartan + chlorthalidone
干预措施: HGP0608 (Drug)
HGP0904+HGP0608+HGP1405
Experimental
amlodipine + losartan + chlorthalidone
干预措施: HGP1405 (Drug)
HGP0904
Active Comparator
amlodipine
干预措施: HGP0904 (Drug)
HGP0608
Active Comparator
losartan
干预措施: HGP0608 (Drug)
HGP1405
Active Comparator
chlorthalidone
干预措施: HGP1405 (Drug)
结局指标
主要结局
AUClast
时间窗: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr
AUClast(Area under the curve to the last measurable concentration)
Cmax
时间窗: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr
Cmax(maxium concentration)
次要结局
- Vz/F(0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr)
- Tmax(0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr)
- AUCinf(0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr)
- T1/2(0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr)
- CL/F(0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr)
研究者
研究点 (1)
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