An Open-label, Randomized, Fasting, Single-dose, Two-treatment, Two-period, Crossover, Phase 1 Clinical Trial to Compare and Evaluate the Pharmacokinetics and Safety of "DWJ1511" and "DWC202501" in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 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
PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers
详细描述
This is an open-label, randomized, single-dose, two-treatment, two-period, crossover, phase 1 clinical trial conducted under fasting conditions to compare and evaluate the pharmacokinetics (PK) and safety of DWJ1511 and DWC202501. 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
- •Male or female participants aged ≥19 years and <65 years at the time of screening
- •Body mass index (BMI) between 18 and 30 kg/m² (BMI = weight [kg] / height [m]²)
排除标准
- •Subjects who have participated in a bioequivalence study or any other clinical trial and have received an investigational product within 6 months prior to the first administration.
- •Subjects who have donated whole blood within 8 weeks prior to the first administration, donated blood components within 2 weeks prior to the first administration, or received a blood transfusion within 4 weeks prior to the first administration.
- •Subjects with a history of gastrointestinal surgery that may affect drug absorption (appendectomy and hernia repair are not exclusionary).
研究组 & 干预措施
A(RT)
30 Subjects, Cross-over, Single dose DWC202501 on period 1, Single dose of DWJ1511 on period 2
干预措施: DWJ1511 (Drug)
A(RT)
30 Subjects, Cross-over, Single dose DWC202501 on period 1, Single dose of DWJ1511 on period 2
干预措施: DWC202501 (Drug)
B(TR)
30 Subjects, Cross-over, Single dose DWJ1511 on period 1, Single dose of DWC202501 on period 2
干预措施: DWJ1511 (Drug)
B(TR)
30 Subjects, Cross-over, Single dose DWJ1511 on period 1, Single dose of DWC202501 on period 2
干预措施: DWC202501 (Drug)
结局指标
主要结局
Area under the plasma drug concentration-time curve [AUCt]
时间窗: 0-12 Hours
Area under the plasma drug concentration-time curve \[AUCt\] of DWJ1511 and DWC202501
Maximum plasma concentration [Cmax]
时间窗: 0-12 Hours
Maximum plasma concentration \[Cmax\] of DWJ1511 and DWC202501
次要结局
- Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf](0-12 Hours)