A Study to Compare the Pharmacokinetics of Lafutidine and Irsogladine Maleate Tablet
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Maximum observed concentration(Cmax) of Lafutidine and Irsogladine maleate
研究概览
简要总结
An Open-Label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics of BRI-1501 Tablet and Coadministration of Lafutidine and Irsogladine maleate as Individual Tablets in Healthy Adult 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subject, aged 19- 50 years
排除标准
- •History of clinically significant and active disease
- •History of gastrointestinal disease
- •History of clinically significant hypersensitivity to study drug, any other drug
- •Laboratory test serum AST or ALT > 1.25 times of upper normal range serum total bilirubin > 1.5 times of upper normal range eGFR < 60 ml/min/1.73m² serological test(HBsAg, HCV Ab, HIV Ag/Ab, Syphilis reagin) positive
- •Hypotension or hypertension
- •Pregnant or nursing women
- •Participation in any other study within 90 days
研究组 & 干预措施
Arm A (Lafutidine and Irsogladine maleate --> BRI-1501)
Subjects of Arm A take Lafutidine and Irsogladine maleate Individual tablets at 1st day as period I. And then, after wash out for 35 days, as period II, subjects of Arm A take a BRI-1501 tablet at 36th day
干预措施: BRI-1501 (Drug)
Arm A (Lafutidine and Irsogladine maleate --> BRI-1501)
Subjects of Arm A take Lafutidine and Irsogladine maleate Individual tablets at 1st day as period I. And then, after wash out for 35 days, as period II, subjects of Arm A take a BRI-1501 tablet at 36th day
干预措施: Lafutidine (Drug)
Arm A (Lafutidine and Irsogladine maleate --> BRI-1501)
Subjects of Arm A take Lafutidine and Irsogladine maleate Individual tablets at 1st day as period I. And then, after wash out for 35 days, as period II, subjects of Arm A take a BRI-1501 tablet at 36th day
干预措施: Irsogladine maleate (Drug)
Arm B (BRI-1501 --> Lafutidine and Irsogladine maleate)
Subjects of Arm B take a BRI-1501 tablet at 1st day as period I. And then, after wash out for 35 days, as period II, subjects of Arm B take Lafutidine and Irsogladine maleate Individual tablets at 36th day
干预措施: BRI-1501 (Drug)
Arm B (BRI-1501 --> Lafutidine and Irsogladine maleate)
Subjects of Arm B take a BRI-1501 tablet at 1st day as period I. And then, after wash out for 35 days, as period II, subjects of Arm B take Lafutidine and Irsogladine maleate Individual tablets at 36th day
干预措施: Lafutidine (Drug)
Arm B (BRI-1501 --> Lafutidine and Irsogladine maleate)
Subjects of Arm B take a BRI-1501 tablet at 1st day as period I. And then, after wash out for 35 days, as period II, subjects of Arm B take Lafutidine and Irsogladine maleate Individual tablets at 36th day
干预措施: Irsogladine maleate (Drug)
结局指标
主要结局
Maximum observed concentration(Cmax) of Lafutidine and Irsogladine maleate
时间窗: 0~36 hour after medication
Area under the plasma drug concentration-time curve(AUClast) of Lafutidine and Irsogladine maleate
时间窗: 0~36 hour after medication
次要结局
未报告次要终点