临床试验/NCT01514903

NCT01514903已完成1 期

Pharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers

Hanmi Pharmaceutical Company Limited1 个研究点分布在 1 个国家目标入组 54 人开始时间: 2011年12月最近更新: 2016年10月12日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 54
试验地点: 1
主要终点: AUC and Cmax of sildenafil

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a single dose open-label comparative pharmacokinetic study to assess the pharmacokinetic characteristics of sildenafil between HIP0908 (chewable tablet) and Viagra (tablet) in healthy male subjects.

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 45 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•age between 20 and 45
•weight : over 55kg and 18.5 < BMI, 25.0
•have to give their consent to participating clinical trial by oneself

排除标准

•has a medical history of hypersensitivity to drug including PDE5 inhibitor and QTc > 430ms or uncontrolled arrhythmia

研究组 & 干预措施

viagra,anti-erectile dysfunction agent

Active Comparator

干预措施: viagra (Drug)

HIP0908

Experimental

干预措施: HIP0908 (Drug)

结局指标

主要结局

AUC and Cmax of sildenafil

时间窗: Pre-dose (0h), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hr post-dose

次要结局

未报告次要终点

研究者

发起方

Hanmi Pharmaceutical Company Limited

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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