NCT06618079进行中（未招募）1 期
A Two Cohort, Single-sequence, Parallel, Open Label, Multiple Oral Dosing Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of HUC2-565-A and HUC2-565-B in Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- AUCtau,ss
研究概览
简要总结
The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety.
详细描述
Cohort A: To evaluate the effect of S-Amlodipine on the pharmacokinetics of Azilsartan at steady state.
Cohort B: To evaluate the effect of Azilsartan on the pharmacokinetics of S-Amlodipine at steady state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort A
Experimental
Evaluate the effect of S-Amlodipine on the pharmacokinetic properties of Azilsartan under steady states.
干预措施: HUC2-565-A, HUC2-565-A and HUC2-565-B (Drug)
Cohort B
Experimental
Evaluate the effect of Azilsartan on the pharmacokinetic properties of S-amlodipine under steady states.
干预措施: HUC2-565-B, HUC2-565-A and HUC2-565-B (Drug)
结局指标
主要结局
AUCtau,ss
时间窗: 0-14days
Pharmacokinetic parameter
Cmax,ss
时间窗: 0-14days
Pharmacokinetic parameter
次要结局
- Metabolic ratio(0-14days)
- PTF(Peak-to-trough fluctuation)(0-14days)
- T1/2,ss(0-14days)
- CLss/F(0-14days)
- AUCinf,ss(0-14days)
- Tmax,ss(0-14days)
- Vdss/F(0-14days)
- Cmin,ss(0-14days)
- Cav,ss(0-14days)
研究者
研究点 (1)
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