An Open-label, Randomized, Multiple-dose Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Tadalafil and Tamsulosin in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tadalafil,Tamsulosin Cmax,ss
研究概览
简要总结
We investigate the potential pharmacokinetic drug-drug interaction between Tadalafil and Tamsulosin in healthy male volunteers who receive Tadalafil alone, Tamsulosin alone, and both together in a 3 period repeatedly.
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
- 19 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 to 55 years.
- •The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
- •Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
排除标准
- •Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
- •Liver enzyme (AST, ALT) level exceeds one and a half times more than maximum normal range.
- •Systolic blood pressure <90mmHg or Diastolic blood pressure < 70 mmHg, systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg(Sitting blood pressure) during the screening procedure.
研究组 & 干预措施
Sequence 3
Tamsulosin→Tadalafil+Tamsulosin→Tadalafil
干预措施: Tamsulosin (Drug)
Sequence 1
Tadalafil→Tamsulosin→Tadalafil+Tamsulosin
干预措施: Tadalafil (Drug)
Sequence 1
Tadalafil→Tamsulosin→Tadalafil+Tamsulosin
干预措施: Tamsulosin (Drug)
Sequence 1
Tadalafil→Tamsulosin→Tadalafil+Tamsulosin
干预措施: Tadalafil + Tamsulosin (Drug)
Sequence 2
Tadalafil+Tamsulosin→Tadalafil→Tamsulosin
干预措施: Tadalafil (Drug)
Sequence 2
Tadalafil+Tamsulosin→Tadalafil→Tamsulosin
干预措施: Tamsulosin (Drug)
Sequence 2
Tadalafil+Tamsulosin→Tadalafil→Tamsulosin
干预措施: Tadalafil + Tamsulosin (Drug)
Sequence 3
Tamsulosin→Tadalafil+Tamsulosin→Tadalafil
干预措施: Tadalafil (Drug)
Sequence 3
Tamsulosin→Tadalafil+Tamsulosin→Tadalafil
干预措施: Tadalafil + Tamsulosin (Drug)
结局指标
主要结局
Tadalafil,Tamsulosin Cmax,ss
时间窗: 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
Tadalafil,Tamsulosin AUCτ
时间窗: 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
次要结局
- Tadalafil,Tamsulosin CL/Fss(6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14))
- Tadalafil,Tamsulosin Vd/Fss(6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14))
- Tadalafil,Tamsulosin tmax,ss(6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14))
- Tadalafil,Tamsulosin Cmin,ss(6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14))
- Tadalafil,Tamsulosin t1/2(6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14))
- Tadalafil,Tamsulosin Cav(6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14))