A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Investigate the Drug Interaction of DWP16001 and DWC202010 After Oral Administration in Healthy Adults
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUCtau,ss) of DWC202010
研究概览
简要总结
This study aims to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety of co-administration of DWP16001 2 mg and DWC202010 (DWC202010 37.5 mg) in healthy adults compared to the case of administration alone.
详细描述
The study design is a randomized, open-label, multiple-dose, crossover clinical trial. The patients were randomly assigned to each group. Primary endpoint was Cmax,ss and AUCtau,ss of DWP16001 and DWC202010. Secondary endpoints were Cmax,ss, Tmax,ss, t1/2, CLss/F, fluctuation of DWP16001 and DWC202010, and Cmax,ss, Cmin,ss, AUCtau,ss, Tmax,ss, and metabolic ratio of DWP16001 metabolites(M1).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intervention: DWP16001 A mg
干预措施: DWP16001 (Drug)
Intervention: DWC202010 B mg
干预措施: DWP202010 (Drug)
Intervention: DWP16001 A mg + DWC202010 B mg
干预措施: DWP16001 (Drug)
Intervention: DWP16001 A mg + DWC202010 B mg
干预措施: DWP202010 (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUCtau,ss) of DWC202010
时间窗: Before IP administration and post-dose up to 24 hours
Peak Plasma Concentration (Cmax,ss) of DWP16001
时间窗: Before IP administration of Day 1, Day 5, and Day 6
Area under the plasma concentration versus time curve (AUCtau,ss) of DWP16001
时间窗: Before IP administration of Day 1, Day 5, and Day 6
Peak Plasma Concentration (Cmax,ss) of DWC202010
时间窗: Before IP administration and post-dose up to 24 hours
次要结局
未报告次要终点