NCT05723549已完成1 期
A Randomized, Open-label, Single-Dose, Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1803 in Healthy Male Volunteers.
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年2月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
A randomized, open-label, single-dose parallel study to evaluate the pharmacokinetics, safety and tolerability of HCP1803 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 clinically accepted dual contraceptives up to 14 days after the last administration date of the investigational product 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
Experimental
Period1 : HCP1803-3
干预措施: HCP1803-3 (Drug)
group2
Active Comparator
Period1 : RLD2002, HCP1904-1
干预措施: RLD2002 (Drug)
group2
Active Comparator
Period1 : RLD2002, HCP1904-1
干预措施: HCP1904-1 (Drug)
结局指标
主要结局
Cmax
时间窗: 0~144hours
pharmacokinetic evaluation
AUC last
时间窗: 0~144hours
pharmacokinetic evaluation
次要结局
- t1/2(0~144hours)
- CL/F(0~144hours)
- AUC inf(0~144hours)
- Tmax(0~144hours)
- Vd/F(0~144hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.HealthyNCT05407220Hanmi Pharmaceutical Company Limited16
已完成
2 期
A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy VolunteersHepatic ImpairmentNCT01621633Novartis Pharmaceuticals32
已完成
1 期
A Study on the Effect of Renal Impairment on the Pharmacokinetics of RO4917838Healthy VolunteerNCT01510899Hoffmann-La Roche12
已完成
1 期
Study to Compare and Assess the Safety and Pharmacokinetic Characteristics After Oral Administration of Fimasartan (BR-A-657∙K) in Healthy Elderly and Young Male VolunteersEssential HypertensionNCT00937534Boryung Pharmaceutical Co., Ltd22
已完成
1 期
PK of Serelaxin in Severe Renal Impairment and ESRDRenal Failure, ChronicEnd-Stage Renal DiseaseNCT01875523Novartis Pharmaceuticals36