NCT02447367已完成1 期
Randomized, Open-label, Single Dose, Two-way Crossover, Clinical Trial to Investigate the Effect of Food on the Pharmacokinetic of JLP-1207 After Oral Administration in Healthy Male Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- AUClast, Cmax, AUCinf
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
A randomized, open-label, single dose, two-way crossover study
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
JLP-1207, Fasted followed by fed
Experimental
JLP-1207 dosing in the fasted state followed by fed dosing
干预措施: JLP-1207(Fasted) (Drug)
JLP-1207, Fed followed by fasted
Experimental
JLP-1207 dosing in the fed state followed by fasted dosing
干预措施: JLP-1207(Fed) (Drug)
结局指标
主要结局
AUClast, Cmax, AUCinf
时间窗: 192 hours
次要结局
- Tmax(192 hours)
- t1/2(192 hours)
- CL/F(192 hours)
研究者
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