NCT01928563Unknown1 期
A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax and AUClast of Udenafil and Dapoxetine
研究概览
简要总结
This study is designed to investigate the pharmacokinetic drug interaction between Udenafil and Dapoxetine in healthy male subjects
Design : Randomized, open-label, 3-treatment, 6-sequence, 3-period crossover study
Investigational Product : Udenafil, Dapoxetine
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
- •Male volunteers in the age between 20 and 45 years old at screening
- •Body mass index(BMI) in the range of 19 to 27 ㎏/㎡
- •Sitting position blood pressure down to meet the criteria at the time of screening (90mmHg≤Systolic blood pressure≤140mmHg)
排除标准
- •History of clinically significant disease or kidney, liver and biliary system, digestive system, respiratory, musculoskeletal, endocrine, neurological psychiatric blood and tumor system, cardiovascular system, etc.
- •History of gastrointestinal diseases or gastrointestinal operation which might affect the study drug absorption
- •Clinically significant hypersensitivity or with a history of hypersensitivity reactions to Udenafil, Dapoxetine ingredients that included elements of the same family of drugs, or other medications
- •≥ 1.5 fold of normal upper limit(UNL) in the level of ALT, AST
- •Alcohol, excessive intake (>21 units/week)
- •Excessive smoker (>10 cigarette/day)
研究组 & 干预措施
Dapoxetine
Experimental
Dapoxetine is administered
干预措施: Dapoxetine (Drug)
Udenafil
Experimental
Udenafil is administered
干预措施: Udenafil (Drug)
Udenafil and Dapoxetine
Experimental
Udenafil and Dapoxetine are co-administered
干预措施: Udenafil+Dapoxetine (Drug)
结局指标
主要结局
Cmax and AUClast of Udenafil and Dapoxetine
时间窗: Blood gathering point : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h (each period)
次要结局
- AUC0-00, Tmax, T1/2β of Udenafil and Dapoxetine AUClast, Cmax, Tmax, t1/2β of DA-8164(major metabolite of Udenafil) and Desmethyl dapoxetine(major metabolite of Dapoxetine)(0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h (each period))
研究者
研究点 (1)
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