A Randomized, Open-Label, Crossover, Single-Dose Study to Compare Pharmacokinetic Properties and Safety After Administration of HCP1303 Capsule and Co-administration of HGP1201 Tablet, HIP1402 Capsule 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
- AUClast
研究概览
简要总结
To investigate the pharmacokinetic properties and safety after administration of HCP1303 and co-administration of HGP1201, HIP1402 in healthy male volunteers
详细描述
The purpose of this study is to investigate the pharmacokinetic properties and safety after administration of HCP1303 and co-administration of HGP1201, HIP1402 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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteer, age 20~55 years
- •The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
- •Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
- •Subject who has the ability and willingness to participate the whole period of trial
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.
- •History of relevant drug allergies or clinically significant hypersensitivity reaction.
- •Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
- •Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
- •SBP: lower than 90mmHg or higher than 150mmHg, DBP: lower thatn 60mmHg or higher than 100mmHg
- •Subjects who judged ineligible by the investigator.
研究组 & 干预措施
Sequence 1
T → R
T : HCP1303 R : HGP1201 + HIP1402
干预措施: HCP1303 (Drug)
Sequence 1
T → R
T : HCP1303 R : HGP1201 + HIP1402
干预措施: HGP1201 (Drug)
Sequence 1
T → R
T : HCP1303 R : HGP1201 + HIP1402
干预措施: HIP1402 (Drug)
Sequence 2
R → T
T : HCP1303 R : HGP1201 + HIP1402
干预措施: HCP1303 (Drug)
Sequence 2
R → T
T : HCP1303 R : HGP1201 + HIP1402
干预措施: HGP1201 (Drug)
Sequence 2
R → T
T : HCP1303 R : HGP1201 + HIP1402
干预措施: HIP1402 (Drug)
结局指标
主要结局
AUClast
时间窗: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose
Cmax
时间窗: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose
次要结局
- tmax(Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose)
- t1/2(Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose)
- Cl/F(Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose)
- Vd/F(Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose)
- AUCinf(Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose)