NCT02088008Unknown1 期
A Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and Valsartan 160mg in Comparison to Each Component Coadministered in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
A randomized, open-label, single dosing, two-way crossover clinical trial to compare the safety/tolerability and pharmacokinetics of the combination of Cilnidipine 10mg and Valsartan 160mg in comparison to each component coadministered 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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 20 and 40
- •Signed informed consent
排除标准
- •Has a history of hypersensitivity to IP ingredients
- •Hypertension or hyportension
研究组 & 干预措施
cilnidipine/valsartan
Experimental
cilnidipine/valsartan tablet
干预措施: cinidipine, valsartan (Drug)
cilnidipine+valsartan
Active Comparator
coadministration of cilnidipine and valsartan
干预措施: cinidipine, valsartan (Drug)
结局指标
主要结局
Cmax
时间窗: 0~24hrs
AUClast
时间窗: 0~24hrs
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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