A Randomized, Open-label, Multiple Dose, Three-treatment, Three-period, Six-sequence Williams Design to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Bosentan After Oral Administration in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Udenafil, Bosentan AUC tau,ss
研究概览
简要总结
This study is designed to investigate the pharmacokinetic drug interaction and safety after oral administration of Udenafil(DA-8159) and Bosentan in healthy volunteers.
Design: Randomized, open-label, multiple-dose, three-treatment, three-period, six-sequence, Williams design
Investigational Product: Udenafil, Bosentan
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
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers between the ages of 20 to 45 years old within the range of BMI between 18.5 and 25(Body Mass Index)
- •having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
- •doctor determines to be suitable as subjects within 4 weeks ago before administration
排除标准
- •Hypersensitivity(or history of hypersensitivity) to Udenafil, Bosentan and PDE5 inhibitors
- •Active Liver Diseases or exceed 1.25 times the normal range of AST, ALT
- •Gastrointestinal diseases or surgeries that affect absorption of drug
- •Excessive drinking(exceed 210g/week) and excessive caffeine(exceed 5cups/day)
- •Smoking over 10 cigarettes per day
- •pregnant or nursing female volunteers
研究组 & 干预措施
Udenafil
干预措施: Udenafil (Drug)
Bosentan
干预措施: Bosentan (Drug)
Udenafil/Bosentan
干预措施: Udenafil/Bosentan (Drug)
结局指标
主要结局
Udenafil, Bosentan AUC tau,ss
时间窗: Blood gathering point: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12h of D1, D15, D29(if Udenafil adminstrated alone), 0 h of D7, D21, D35, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 h of D8, D22, D36
Udenafil, Bosentan C max,ss
时间窗: Blood gathering point: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12h of D1, D15, D29(if Udenafil adminstrated alone), 0 h of D7, D21, D35, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 h of D8, D22, D36
次要结局
未报告次要终点