NCT07181538已完成1 期
Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "JLP-2302" and "JP-1366" in Healthy Volunteers
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 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
This study aims to evaluate the pharmacokinetics and the safety after administration of "JLP-2302" and "JP-1366" in healthy volunteers.
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 mass index (BMI) between 18.0 and 30.0 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 taken enzyme-inducing or -inhibiting drugs
- •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
JLP-2302 and JP-1366 crossover
Experimental
干预措施: JLP-2302 (Drug)
JLP-2302 and JP-1366 crossover
Experimental
干预措施: JP-1366 (Drug)
JP-1366 and JLP-2302 crossover
Active Comparator
干预措施: JLP-2302 (Drug)
JP-1366 and JLP-2302 crossover
Active Comparator
干预措施: JP-1366 (Drug)
结局指标
主要结局
Area under the plasma drug concentration-time curve(AUCt)
时间窗: Pre-dose on Day 1 and on Days 2 post-dose
Peak Plasma Concentration (Cmax)
时间窗: Pre-dose on Day 1 and on Days 2 post-dose
次要结局
未报告次要终点
研究者
研究点 (1)
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