An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1801 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Cmax of Tamsulosin
研究概览
简要总结
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HIP1801 in healthy male subjects.
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
- •Age 19~45 years in healthy male volunteers
- •BMI is more than 18.5 kg/m^2 , no more than 29.9 kg/m^2
- •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 digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- •Subjects who judged ineligible by the investigator
研究组 & 干预措施
Sequence 1
Period 1 : Fasted state + HIP1402, Period 2 : Fasted state + HIP1801
干预措施: HIP1402 (Drug)
Sequence 1
Period 1 : Fasted state + HIP1402, Period 2 : Fasted state + HIP1801
干预措施: HIP1801 (Drug)
Sequence 2
Period 1 : Fasted state + HIP1801, Period 2 : Fasted state + HIP1402
干预措施: HIP1402 (Drug)
Sequence 2
Period 1 : Fasted state + HIP1801, Period 2 : Fasted state + HIP1402
干预措施: HIP1801 (Drug)
Sequence 3
High fat diet + HIP1402, Period 2 : High fat diet + HIP1801
干预措施: HIP1402 (Drug)
Sequence 3
High fat diet + HIP1402, Period 2 : High fat diet + HIP1801
干预措施: HIP1801 (Drug)
Sequence 4
High fat diet + HIP1801, Period 2 : High fat diet + HIP1402
干预措施: HIP1402 (Drug)
Sequence 4
High fat diet + HIP1801, Period 2 : High fat diet + HIP1402
干预措施: HIP1801 (Drug)
结局指标
主要结局
Cmax of Tamsulosin
时间窗: pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour
pharmacokinetic evaluation
AUClast of Tamsulosin
时间窗: pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour
pharmacokinetic evaluation
次要结局
- AUCinf of Tamsulosin(pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour)
- Tmax of Tamsulosin(pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour)
- t1/2 of Tamsulosin(pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour)
- CL/F of Tamsulosin(pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour)
- Vd/F of Tamsulosin(pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour)