NCT05663073已完成1 期
A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of Irbesartan/Amlodipine Fixed Dose Combination in Comparison With Co-administration of Mono Compounds in Healthy 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
- 发起方
- Handok Inc.
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Cmax of Irbesartan and Amlodipne
研究概览
简要总结
The purpose of this study is to compare pharmacokinetics and safety of Irbesartan and Amlodipine Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Patients who are 19 years or older on screening
- •Signed informed consent
- •Healthy Volunteer
- •Other inclusion applies
排除标准
- •Clinically relevant/significant findings as evaluated by the investigator
- •Other exclusion applied
研究组 & 干预措施
Co-administration of Irbesartan and Amlodipine
Experimental
participants will receive one table each of Irbesartan and Amlodipine in a crossover design
干预措施: Amlodipine (Drug)
Irbesartan/Amlodipine Fixed dose combination
Experimental
participants will receive one tablet of Irbesartan/Amlodipine FDC in a crossover design
干预措施: Irbesartan/Amlodipine FDC (Drug)
Co-administration of Irbesartan and Amlodipine
Experimental
participants will receive one table each of Irbesartan and Amlodipine in a crossover design
干预措施: Irbesartan (Drug)
结局指标
主要结局
Cmax of Irbesartan and Amlodipne
时间窗: 72 hours
AUCt of Irbesartan and Amlodipne
时间窗: 72 hours
次要结局
- tmax of Irbesartan and Amlodipine(72 hours)
- CL/F of Irbesartan and Amlodipine(72 hours)
- AUCinf of Irbesartan and Amlodipine(72 hours)
- Vz/F of Irbesartan and Amlodipine(72 hours)
- AUCt/AUCinf of Irbesartan and Amlodipine(72 hours)
- half-life of Irbesartan and Amlodipine(72 hours)
研究者
研究点 (1)
Loading locations...
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