Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315 in Healthy Adult Volunteers Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 主要终点
- The maximum serum concentration(Cmax) of DWJ1589 and DWC202315
研究概览
简要总结
This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1589 and DWC202315 in healty adult volunteers.
详细描述
The study design is a Randomized, Open-label, Oral, Single-dose, 2 × 4 crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWJ1589 and DWC202315. Secondary endpoints were AUCinf, AUClast/AUCinf, Tmax and t1/2 of DWJ1589 and DWC202315.
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
- •Healthy adult volunteers
排除标准
- •with a history of mental disorder
- •For female volunteers, those who are suspected of being pregnant or lactating
研究组 & 干预措施
Sequence A: RTRT
T: DWJ1589 R: DWC202315
干预措施: Period 4 (Drug)
Sequence B: TRTR
T: DWJ1589 R: DWC202315
干预措施: Period 1 (Drug)
Sequence B: TRTR
T: DWJ1589 R: DWC202315
干预措施: Period 2 (Drug)
Sequence B: TRTR
T: DWJ1589 R: DWC202315
干预措施: Period 3 (Drug)
Sequence B: TRTR
T: DWJ1589 R: DWC202315
干预措施: Period 4 (Drug)
Sequence A: RTRT
T: DWJ1589 R: DWC202315
干预措施: Period 2 (Drug)
Sequence A: RTRT
T: DWJ1589 R: DWC202315
干预措施: Period 3 (Drug)
Sequence A: RTRT
T: DWJ1589 R: DWC202315
干预措施: Period 1 (Drug)
结局指标
主要结局
The maximum serum concentration(Cmax) of DWJ1589 and DWC202315
时间窗: At pre-dose (0 hour), and post-dose 0.83 to 72 hour.
Cmax of DWJ1589 and DWC202315
The Area under the curve(AUC)last of DWJ1589 and DWC202315
时间窗: At pre-dose (0 hour), and post-dose 0.83 to 72 hour.
AUClast of DWJ1589 and DWC202315
次要结局
未报告次要终点