An Open-Label, Randomized, Single-Dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- AUClast of EXP3174
研究概览
简要总结
An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination of HCP1904 and Co-Administration of RLD2001-2 and RLD2006 Tablets in Healthy 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
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19~45 years in healthy volunteers
- •BMI is more than 18.5 kg/m^2 , no more than 29.9 kg/m^2
- •Subjects who agree to use medically accepted dual contraceptives up to two months after the last administration date of the clinical trial drug and not to provide sperm.
- •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 (Reference-Test)
Period 1: RLD2001-2 + RLD2006, Period2: HCP1904-1
干预措施: HCP1904-1 (Drug)
Sequence 1 (Reference-Test)
Period 1: RLD2001-2 + RLD2006, Period2: HCP1904-1
干预措施: RLD2006 (Drug)
Sequence 1 (Reference-Test)
Period 1: RLD2001-2 + RLD2006, Period2: HCP1904-1
干预措施: RLD2001-2 (Drug)
Sequence 2 (Test-Reference)
Period 1:HCP1904-1, Period 2: RLD2001-2 + RLD2006
干预措施: HCP1904-1 (Drug)
Sequence 2 (Test-Reference)
Period 1:HCP1904-1, Period 2: RLD2001-2 + RLD2006
干预措施: RLD2006 (Drug)
Sequence 2 (Test-Reference)
Period 1:HCP1904-1, Period 2: RLD2001-2 + RLD2006
干预措施: RLD2001-2 (Drug)
结局指标
主要结局
AUClast of EXP3174
时间窗: Day 1, Day 15: pre-dose(0 hour)~48hours
Pharmacokinetic evaluation
Cmax of EXP3174
时间窗: Day 1, Day 15: pre-dose(0 hour)~48hours
Pharmacokinetic evaluation
AUClast of Losartan
时间窗: Day 1, Day 15: pre-dose(0 hour)~48hours
Pharmacokinetic evaluation
Cmax of Chlorthalidone
时间窗: Day 1, Day 15: pre-dose(0 hour)~144hours
Pharmacokinetic evaluation
Cmax of Losartan
时间窗: Day 1, Day 15: pre-dose(0 hour)~48hours
Pharmacokinetic evaluation
AUClast of Chlorthalidone
时间窗: Day 1, Day 15:pre-dose(0 hour)~144hours
Pharmacokinetic evaluation
次要结局
- AUC inf, Tmax, T1/2, Cl/F, Vd/F of EXP3174(Day 1, Day 15: pre-dose(0 hour)~48hours)
- AUC inf, Tmax, T1/2, Cl/F, Vd/F of Chlorthalidone(Day 1, Day 15:pre-dose(0 hour)~144hours)
- AUC inf, Tmax, T1/2, Cl/F, Vd/F of Losartan(Day 1, Day 15: pre-dose(0 hour)~48hours)