A Randomized, Open, Two-sequence, Crossover, Multiple Oral Administrations, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Drug-drug Interaction Between DWP16001, DWC202407, and DWC202408 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Cmax,ss of DWC202407
研究概览
简要总结
This study aims to evaluate the pharmacokinetic/pharmacodynamic drug-drug interactions between DWP16001, DWC202407, and DWC202408 in healthy adults
详细描述
This study aims to evaluate the pharmacokinetic interactions, pharmacodynamic interactions, safety, and tolerability of DWP16001, DWC202407, and DWC202408 in 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
- •Healthy adult volunteers aged 19 to 50 years at the time of screening.
- •Individuals with a body weight between 50.0 kg and 90.0 kg and a Body Mass Index (BMI) between 18.5 kg/m² and 29.9 kg/m² at the time of screening.
- •Female volunteers must be neither pregnant nor breastfeeding, or must be in a surgically sterile state (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy).
- •Individuals who have been fully informed about the clinical trial, have fully understood the details, voluntarily decided to participate, and provided written consent to comply with the precautions.
排除标准
- 未提供
研究组 & 干预措施
Enavogliflozin 0.3mg, once daily
干预措施: DWP16001 0.3mg (Drug)
Metformin 1,000mg, BID
干预措施: DWC202407 1,000mg (Drug)
Glimepiride 2mg, once daily
干预措施: DWC202408 2mg (Drug)
结局指标
主要结局
Cmax,ss of DWC202407
时间窗: 0-12 hours
Peak Plasma Concentration at steady-state
AUCtau,ss of DWC202407
时间窗: 0-12 hours
Area under the plasma concentration versus time curve at Tau, steady-state
Cmax,ss of DWC202408
时间窗: 0-24 hours
Peak Plasma Concentration at steady-state
AUCtau,ss of DWC202408
时间窗: 0-24 hours
Area under the plasma concentration versus time curve at Tau, steady-state
Cmax,ss of DWP16001
时间窗: 0-24 hours
Peak Plasma Concentration at steady-state
AUCtau,ss of DWP16001
时间窗: 0-24 hours
Area under the plasma concentration versus time curve at Tau, steady-state
次要结局
未报告次要终点