Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- AUCτ,ss, Cmax,ss
研究概览
简要总结
The purpose of this study is to investigate the pharmacokinetic drug interaction between Solifenacin and Tamsulosin in healthy male volunteers.
详细描述
Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •19~45 years healthy male
- •Body weight is over 55kg, BMI measurement 18.0kg/m^2~ 27.0kg/m^2
- •Signed informed consent form from to participate voluntarily and to comply with the trial requirements.
- •Researchers determined suitable volunteers through physical examination, laboratory tests
排除标准
- •History of clinically significant liver, kidneys, nervous system, immune system, respiratory, endocrine disorders or tumor or blood disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)
- •Sitting SBP>150mmHg or <100mmHg, sitting DBP>100mmHg or <60mmHg, after 3 minutes break
- •An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
- •Have a gastrointestinal disease history that can affect drug absorption (Crohn's disease ulcers, etc) or surgery (except simple appendectomy or hernia surgery)
- •History of drug abuse
- •Positive urine drug screening
- •Administrated investigational product in a previous clinical trial within 90 days of the first administration day in this study.
- •Donated blood within 60 days prior to the first administration day in this study.
研究组 & 干预措施
Tamsulosin 1
Volunteers will be taken Tamsulosin and solifenacin
干预措施: Solifenacin (Drug)
Tamsulosin 1
Volunteers will be taken Tamsulosin and solifenacin
干预措施: Tamsulosin and solifenacin (Drug)
Solifenacin 1
Volunteers will be taken Tamsulosin and solifenacin
干预措施: Tamsulosin (Drug)
Solifenacin 1
Volunteers will be taken Tamsulosin and solifenacin
干预措施: Tamsulosin and solifenacin (Drug)
Co-administration 1
Volunteers will be taken Tamsulosin and solifenacin
干预措施: Tamsulosin (Drug)
Co-administration 1
Volunteers will be taken Tamsulosin and solifenacin
干预措施: Solifenacin (Drug)
Tamsulosin 2
Volunteers will be taken Tamsulosin and solifenacin
干预措施: Solifenacin (Drug)
Tamsulosin 2
Volunteers will be taken Tamsulosin and solifenacin
干预措施: Tamsulosin and solifenacin (Drug)
Solifenacin 2
Volunteers will be taken Tamsulosin and solifenacin
干预措施: Tamsulosin (Drug)
Solifenacin 2
Volunteers will be taken Tamsulosin and solifenacin
干预措施: Tamsulosin and solifenacin (Drug)
Co-administration 2
Volunteers will be taken Tamsulosin and solifenacin
干预措施: Tamsulosin (Drug)
Co-administration 2
Volunteers will be taken Tamsulosin and solifenacin
干预措施: Solifenacin (Drug)
结局指标
主要结局
AUCτ,ss, Cmax,ss
时间窗: 192h
次要结局
- C trough,ss(192h)
- CL/F(192h)
- Tmax,ss(192h)
- t1/2(192h)