An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics and Safety After Administration of HCP1105 Alone and Co-administration of HGP0918 and HGP0816 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Cmax of Rosuvastatin
研究概览
简要总结
To investigate the pharmacokinetic properties and safety after administration of HCP1105 and co-administration of HGP0918, HGP0816 in healthy male volunteers
详细描述
The purpose of this study is to investigate the pharmacokinetic properties and safety after administration of HCP1105 and co-administration of HGP0918, HGP0816 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •Healthy male volunteers, aged 19 to 55 years.
- •The result of Body Mass Index(BMI) is not less than 18.5 kg/m2 , no more than 27.0 kg/m2
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
- •Someone has a declined liver function and Liver enzyme (AST, ALT or total bilirubin) level exceeds more than one and a half times normal upper range
- •Somenone has a declined kidney function and his eGFR < 60mL/min/1.73m2
研究组 & 干预措施
Sequence 1
T → R
T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab
干预措施: HCP1105 (Drug)
Sequence 1
T → R
T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab
干预措施: HCP0918 (Drug)
Sequence 1
T → R
T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab
干预措施: HCP0816 (Drug)
Sequence 2
R → T
T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab
干预措施: HCP1105 (Drug)
Sequence 2
R → T
T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab
干预措施: HCP0918 (Drug)
Sequence 2
R → T
T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab
干预措施: HCP0816 (Drug)
结局指标
主要结局
Cmax of Rosuvastatin
时间窗: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
baseline-corrected Cmax of DHA total lipid & EPA total lipid
时间窗: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
baseline-corrected AUCt of DHA total lipid & EPA total lipid
时间窗: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
AUCt of Rosuvastatin
时间窗: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
次要结局
- Tmax of Rosuvastatin(0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13))
- AUCt of DHA total lipid & EPA total lipid(-20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16))
- Tmax of DHA total lipid & EPA total lipid(-20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16))
- baseline-corrected partial AUC12/24/48 of DHA total lipid & EPA total lipid(-20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16))
- CL/F of Rosuvastatin(0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13))
- Vdz/F of Rosuvastatin(0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13))
- Cmax of DHA total lipid & EPA total lipid(-20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16))
- t1/2β of DHA total lipid & EPA total lipid(-20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16))
- t1/2β of Rosuvastatin(0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13))
- AUC∞ of Rosuvastatin(0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13))