NCT01651858已完成1 期
Nurigra Chewable Tablet in Healthy Adult Male Volunteers
Daewoong Pharmaceutical Co. LTD.0 个研究点目标入组 52 人开始时间: 2012年2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
- 52
- 主要终点
- to Assess Pharmacokinetics
研究概览
简要总结
The purpose of this study is to evaluate pharmacokinetics of sildenafil citrate 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
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy and male subjects aged 20 to 45 years
- •A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
- •A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints.
排除标准
- •A subject with sign or symptoms or previously diagnosed disease of liver
研究组 & 干预措施
Nurigra Chewable tablet
Experimental
干预措施: Nurigra Chewable tablet (Drug)
Viagra
Active Comparator
干预措施: Nurigra Chewable tablet (Drug)
结局指标
主要结局
to Assess Pharmacokinetics
时间窗: 24h after drug administration
AUC and Cmax in plasma
次要结局
- to Assess Safety(24h after administration)
研究者
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