A Randomized, Open-label, Oral Single Dose, Two-way Crossover Clinical Trial to Compare the Pharmacokinetics and Safety/Tolerability After Administration of HCP1401 and Co-administration of HCP0605 and HGP1405 in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- AUClast
研究概览
简要总结
A randomized, open-label, oral single dose, two-way crossover clinical trial to compare the pharmacokinetics and safety/tolerability after administration of HCP1401 and co-administration of HCP0605 and HGP1405 in healthy male volunteers
详细描述
The purpose of this study is to investigate the pharmacokinetics and safety/tolerability after administration of HCP1401 and co-administration of HCP0605, HGP1405 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
- •Healthy male volunteer, age 19~45 years
- •Weight is not less than 55kg, no more than 90kg and Body Mass Index(BMI) is not less than 18 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.
- •Subjects who judged ineligible by the investigator.
研究组 & 干预措施
Sequence A
Period 1 : HCP0605+HGP1405
Period 2 : HCP1401
干预措施: HCP0605 (Drug)
Sequence A
Period 1 : HCP0605+HGP1405
Period 2 : HCP1401
干预措施: HGP1405 (Drug)
Sequence A
Period 1 : HCP0605+HGP1405
Period 2 : HCP1401
干预措施: HCP1401 (Drug)
Sequence B
Period 1 : HCP1401
Period 2 : HCP0605+HGP1405
干预措施: HCP0605 (Drug)
Sequence B
Period 1 : HCP1401
Period 2 : HCP0605+HGP1405
干预措施: HGP1405 (Drug)
Sequence B
Period 1 : HCP1401
Period 2 : HCP0605+HGP1405
干预措施: HCP1401 (Drug)
结局指标
主要结局
AUClast
时间窗: pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose
Area under the plasma concentration versus time curve
Cmax
时间窗: pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose
Peak Plasma Concentration
次要结局
- AUCinf(pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose)
- T1/2(pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose)
- Cl/F(pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose)
- Vz/F(pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose)
- Tmax(pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose)