A Randomized, Open-Label, Two-way Crossover, Single-Dose Study to Compare Pharmacokinetic Properties and Safety After Administration of HCP1306 Tablet and Co-administration of HGP0816 Tablet, HGP1404 Tablet in the Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- AUClast of Free Ezetimibe
研究概览
简要总结
The purpose of this study is to evaluate Pharmacokinetic Properties and Safety after administration of HCP1306 tablet and Co-administration of HGP0816 tablet, HGP1404 tablet in the healthy adults.
详细描述
A Randomized, Open-Label, Two-way Crossover, Single-Dose Study to Compare Pharmacokinetic Properties and Safety after administration of HCP1306 tablet and Co-administration of HGP0816 tablet, HGP1404 tablet in the healthy adults
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
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group1
C → A + B
A : HGP0816 B : HGP1404 C : HCP1306
干预措施: HGP0816 (Drug)
Group1
C → A + B
A : HGP0816 B : HGP1404 C : HCP1306
干预措施: HGP1404 (Drug)
Group1
C → A + B
A : HGP0816 B : HGP1404 C : HCP1306
干预措施: HCP1306 (Drug)
Group2
A + B → C
A : HGP0816 B : HGP1404 C : HCP1306
干预措施: HGP0816 (Drug)
Group2
A + B → C
A : HGP0816 B : HGP1404 C : HCP1306
干预措施: HGP1404 (Drug)
Group2
A + B → C
A : HGP0816 B : HGP1404 C : HCP1306
干预措施: HCP1306 (Drug)
结局指标
主要结局
AUClast of Free Ezetimibe
时间窗: Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours
Cmax of Free Ezetimibe
时间窗: Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours
AUClast of Rosuvastatin
时间窗: Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours
Cmax of Rosuvastatin
时间窗: Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours
次要结局
- AUCinf of Rosuvastatin(Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours)
- CL/F of Rosuvastatin(Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours)
- AUCinf of Free Ezetimibe(Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours)
- Tmax of Free Ezetimibe(Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours)
- Vd/F of Free Ezetimibe(Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours)
- CL/F of Free Ezetimibe(Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours)
- tmax of Rosuvastatin(Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours)
- t1/2 of Rosuvastatin(Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours)
- Vd/F of Rosuvastatin(Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours)
- MRT of Rosuvastatin(Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours)
- T1/2 of Free Ezetimibe(Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours)
- MRT of Free Ezetimibe(Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours)