An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "DWJ1622" and Co-administration of "DWC202313" and "DWC202314" in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This study aims to evaluate the safety and pharmacokinetic characteristics of DWJ1622, DWC202313, and DWC202314 in healthy adult volunteers under fasting conditions.
详细描述
This is an open-label, randomized, oral, single-dose, 2-sequence, 2-period, crossover Phase 1 study designed to compare the pharmacokinetics and safety profiles of DWJ1622 with the co-administration of DWC202313 and DWC202314 in healthy volunteers under fasting conditions. Subjects will be randomized to receive either DWJ1622 or the co-administration of DWC202313 and DWC202314 in different sequences across two study periods with an appropriate washout period.
The primary pharmacokinetic endpoints include the maximum observed plasma concentration (Cmax) and the area under the plasma concentration-time curve to the last measurable concentration (AUClast) of each study drug. Secondary endpoints include the area under the plasma concentration-time curve extrapolated to infinity (AUCinf), the ratio of AUClast to AUCinf (AUClast/AUCinf), the time to reach maximum plasma concentration (Tmax), and the terminal elimination half-life (t1/2). Safety will be evaluated based on adverse events and clinical laboratory tests.
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
DWJ1622
干预措施: DWJ1622 (Drug)
DWJ1622
干预措施: DWC202313, DWC202314 (Drug)
DWC202313, DWC202314
干预措施: DWJ1622 (Drug)
DWC202313, DWC202314
干预措施: DWC202313, DWC202314 (Drug)
结局指标
主要结局
Cmax
时间窗: At pre-dose (0 hours), and post-dose 1 to 72 hours.
Cmax of DWJ1622 and DWC202313, DWC202314
AUClast
时间窗: At pre-dose (0 hours), and post-dose 1 to 72 hours.
AUClast of DWJ1622 and DWC202313, DWC202314
次要结局
- AUCinf(At pre-dose (0 hours), and post-dose 1 to 72 hours.)
- AUClast/AUCinf(At pre-dose (0 hours), and post-dose 1 to 72 hours.)
