NCT06119945招募中1 期
An Open-label, Randomized, 2x4 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1568 and DWC202215 in Healthy Volunteers
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年11月9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
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Cmax,ss of DWJ1568 and DWC202215
研究概览
简要总结
This study aims to compare the pharmacokinetics and safety following administration of DWJ1568 and DWC202215 in healthy volunteers
详细描述
The study design is a Randomized, Open-label, Oral, Single-dose, Four-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUCt of DWJ1568 and DWC202215. Secondary endpoints were AUCinf, Tmax, t1/2 of DWJ1568 and DWC202215.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •over 19 year old
排除标准
- •Galactose intolerance
- •Lapp lactase deficiency
研究组 & 干预措施
DWJ1568
Experimental
DWJ1568
干预措施: DWJ1568 (Drug)
DWC202215
Active Comparator
DWC202215
干预措施: DWC202215 (Drug)
结局指标
主要结局
Cmax,ss of DWJ1568 and DWC202215
时间窗: At pre-dose (0 hour), and post-dose 0 to 72 hour.
AUCt of DWJ1568 and DWC202215
时间窗: At pre-dose (0 hour), and post-dose 0 to 72 hour.
次要结局
- AUCinf of DWJ1568 and DWC202215(At pre-dose (0 hour), and post-dose 0 to 72 hour.)
- Tmax of DWJ1568 and DWC202215(At pre-dose (0 hour), and post-dose 0 to 72 hour.)
- AUCt/AUCinf of DWJ1568 and DWC202215(At pre-dose (0 hour), and post-dose 0 to 72 hour.)
- t1/2 of DWJ1568 and DWC202215(At pre-dose (0 hour), and post-dose 0 to 72 hour.)
研究者
研究点 (1)
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