NCT06010589进行中（未招募）1 期
Bioequivalence Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1558 and Co-administration of DWC202310 and DWC202311 in Healthy Volunteers
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年8月17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
- 进行中（未招募）
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Cmax,ss of DWJ1558
研究概览
简要总结
This study aims to compare the pharmacokinetics and safety following administration of DWJ1558 and co-administration of DWC202310 and DWC202311 in healthy 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 —（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
- •Pancreatitis
- •Diabetic ketoacidosis
研究组 & 干预措施
Intervention: DWJ1558
Experimental
干预措施: DWJ1558 (Drug)
Intervention: DWC202310 and DWC202311
Experimental
干预措施: DWC202310 and DWC202311 (Drug)
结局指标
主要结局
Cmax,ss of DWJ1558
时间窗: At pre-dose (0 hour), and post-dose 1 to 72 hour.
Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1558
AUCt of DWJ1558
时间窗: At pre-dose (0 hour), and post-dose 1 to 72 hour.
Area under the curve from the time of dosing to the last measurable concentration(AUCt) of DWJ1558
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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