NCT01406431已完成1 期
A Single Dose, Sequence-randomized, Open-label, 2x2 Crossover Study to Compare Pharmacokinetics Between Pitavastatin and Valsartan Co-administration and Livalo® Fixed Combination Drug in Healthy Male Subjects
JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2011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
- 48
- 试验地点
- 1
- 主要终点
- Cmax of study drugs after single oral administration
研究概览
简要总结
The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan co-administration and Livalo fixed combination drug in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers
- •Age 20-55 years at the time of Screening
- •BMI 19-26 kg/m2 at the time of Screening
排除标准
- •Received other investigational drug within 90 days prior to the first dose of study drug
研究组 & 干预措施
Pitavastatin + Valsartan
Active Comparator
Intervention: Drug: Pitavastatin, Valsartan
干预措施: Pitavastatin, Valsartan (Drug)
Livalo fixed combination drug
Experimental
Intervention: Drug: Livalo® fixed combination drug
干预措施: Livalo® fixed combination drug (Drug)
结局指标
主要结局
Cmax of study drugs after single oral administration
时间窗: 0-48hrs
AUClast of study drugs after single oral administration
时间窗: 0-48hrs
次要结局
- AUCinf, Tmax and t1/2β of study drugs after single oral administration(0-48hrs)
研究者
研究点 (1)
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