An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence After Administration of "DWJ1445" and "DWC202506" in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Area under the plasma drug concentration-time curve [AUCt]
研究概览
简要总结
A bioequivalence study comparing DWJ1445 and DWC202506 in healthy adults
详细描述
This is an open-label, randomized, single-dose, 2-treatment, 2-period, crossover, bioequivalence study conducted under fasting conditions to compare and evaluate the pharmacokinetics and safety of DWJ1445 and DWC202506 in healthy adult volunteers. Participants will receive both study drugs in separate periods, with a washout interval between administrations. The study aims to assess PK parameters and monitor safety through clinical evaluations and 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with a body mass index (BMI) between 18 and 30 kg/m²
- •Subjects without any clinically significant congenital or chronic disease, and with no pathological findings based on medical examination
- •Subjects who agree to use a medically acceptable method of contraception
排除标准
- •Subjects who have participated in a bioequivalence or other clinical trial and received an investigational product within 6 months prior to the first dose
- •Subjects with a history of gastrointestinal surgery that may affect drug absorption
- •Subjects with a clinically significant history of psychiatric illness Female subjects who are pregnant, suspected of being pregnant, or currently breastfeeding
研究组 & 干预措施
A(RT)
35 subjects, Cross-over, Single dose DWC202506 on period 1, Single dose of DWJ1445 on period 2
干预措施: DWJ1445 (Drug)
A(RT)
35 subjects, Cross-over, Single dose DWC202506 on period 1, Single dose of DWJ1445 on period 2
干预措施: DWC202506 (Drug)
B(TR)
35 subjects, Cross-over, Single dose DWJ1445 on period 1, Single dose of DWC202506 on period 2
干预措施: DWJ1445 (Drug)
B(TR)
35 subjects, Cross-over, Single dose DWJ1445 on period 1, Single dose of DWC202506 on period 2
干预措施: DWC202506 (Drug)
结局指标
主要结局
Area under the plasma drug concentration-time curve [AUCt]
时间窗: 0-24 hours
Area under the plasma drug concentration-time curve \[AUCt\] of DWJ1445 and DWC202506
Maximum plasma concentration [Cmax]
时间窗: 0-24 hours
Maximum plasma concentration \[Cmax\] of DWJ1445 and DWC202506
次要结局
- Area under the plasma drug concentration-time curve from time 0 to infinity(0-24 hours)
- Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf](0-24 hours)
- Time of peak concentration [Tmax](0-24 hours)
- Terminal phase of half-life [t1/2](0-24 hours)