A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DWP16001 Drug A and DWP16001 Drug C in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- AUClast of DWP16001
研究概览
简要总结
This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug C in healty adult volunteers.
详细描述
The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWP16001.
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
- •Subjects with a body weight of ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2
- •☞ BMI (kg/m2) = Body weight (kg) / {Height (m)}2
排除标准
- •musculoskeletal diseases
- •mental diseases
- •hemato-oncologic diseases
研究组 & 干预措施
Intervention: DWP16001 Drug A
1 tablet, Oral, once daily single dose
干预措施: DWP16001 Drug A (Drug)
Intervention: DWP16001 Drug C
1 tablet, Oral, once daily single dose
干预措施: DWP16001 Drug C (Drug)
结局指标
主要结局
AUClast of DWP16001
时间窗: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
The area under the plasma drug concentration-time curve of DWP16001
Cmax,ss of DWP16001
时间窗: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
Peak Plasma Concetration of DWP16001
次要结局
- CL/F of DWP16001(At pre-dose (0 hour), and post-dose 0.25 to 72 hour.)
- T1/2 of DWP16001(At pre-dose (0 hour), and post-dose 0.25 to 72 hour.)
- Vd/F of DWP16001(At pre-dose (0 hour), and post-dose 0.25 to 72 hour.)
- Tmax of DWP16001(At pre-dose (0 hour), and post-dose 0.25 to 72 hour.)