NCT05712681已完成1 期
A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral Single Dose of JP-1366 Tablet in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax of JP-1366
研究概览
简要总结
To Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral single dose of JP-1366 tablet 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A healthy adult aged between 19 and 45 years old
- •BMI between 18.0kg/m2 and 27.0kg/m2 at the time of screening
排除标准
- •The subject who has clinically significant disease with liver, endocrine system, immune system, nervous system, kidney, cardiovascular disease, mental disorder, the blood of tumor disease, respiratory system or with history of the disease.
- •The subject who has a history of gastrointestinal disorders(e.g., gastroesophageal reflux disease, gastrospasm, gastritis, gastrointestinal ulcers, Crohn's disease, etc.) or history of gastrointestinal surgery
- •The subject who has an allergic disease(excluding mild allergic rhinitis that does not require administration) or has a history of clinically significant hypersensitivity or adverse reactions to clinical trial drugs or drugs containing the same or other drugs (aspirin, NSAIDs, antibiotics, etc.).
- •The subject who has other clinically significant diseases or history
- •The subject who has a history of drug abuse
- •The subject who cannot withstand the insertion and maintenance of pH catheters
研究组 & 干预措施
Sequence 1
Experimental
T → Washout period(7-14days) → R
干预措施: JP-1366 20mg tablet (Drug)
Sequence 2
Experimental
R → Washout period(7-14days) → T
干预措施: JP-1366 20mg tablet (Drug)
结局指标
主要结局
Cmax of JP-1366
时间窗: Pre-dose(0 hour) and up to 34 hours in each period
AUClast of JP-1366
时间窗: Pre-dose(0 hour) and up to 34 hours in each period
次要结局
- Gastric pH(Pre-dose(0 hour) up to 24 hours after Investigational product administration)
研究者
研究点 (1)
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