NCT02343250已完成1 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
- 状态
- 已完成
- 入组人数
- 54
- 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
- 19 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 of hypotension
研究组 & 干预措施
Cinidipine/Valsartan tablet
Experimental
Cinidipine/Valsartan tablet
干预措施: Cilnidipine/Valsartan (Drug)
Cinidipine/Valsartan tablet
Experimental
Cinidipine/Valsartan tablet
干预措施: Cilnidipine+Valsartan (Drug)
Cilnidipine+Valsartan
Active Comparator
coadministration of cilinidipine and valsartan
干预措施: Cilnidipine+Valsartan (Drug)
Cilnidipine+Valsartan
Active Comparator
coadministration of cilinidipine and valsartan
干预措施: Cilnidipine/Valsartan (Drug)
结局指标
主要结局
Cmax
时间窗: 0~24hr
AUClast
时间窗: 0~24hr
次要结局
未报告次要终点
研究者
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