A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Cmax of Losartan
研究概览
简要总结
A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Weight ≥ 55kg and BMI 18 ~ 30 kg/m^2
- •Subjects who agree to use medically accepted dual contraceptives up to 14 days 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
group1
Period1: HCP1904-1
干预措施: HCP1904-1 (Drug)
group2
Period1: HCP1904-3
干预措施: HCP1904-3 (Drug)
结局指标
主要结局
Cmax of Losartan
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
t1/2 of Losartan
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
CL/F of Losartan
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Vd/F of Losartan
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
AUC inf of EXP3174
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Cmax of Chlorthalidone
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
AUC last of EXP3174
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
CL/F of EXP3174
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Tmax of Chlorthalidone
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
t1/2 of Chlorthalidone
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
CL/F of Chlorthalidone
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Vd/F of Chlorthalidone
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Tmax of Losartan
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
t1/2 of EXP3174
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
AUC last of Chlorthalidone
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
AUC inf of Chlorthalidone
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
AUC last of Losartan
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
AUC inf of Losartan
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Cmax of EXP3174
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Tmax of EXP3174
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Vd/F of EXP3174
时间窗: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
次要结局
未报告次要终点