An Open-label, Randomized, Single Dose, Crossover Phase I Clinical Trial to Compare Pharmacokinetic Property of SYO-1126 and Glivec Film Coated Tab., 4T (400mg) in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of the AUCt SYO-1126 anf Glivec Film coated tab 4T(400mg)
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by comparing pharmacokinetics characteristics between the SYO-1126 and Glivec Film Coated tab 4T (400mg) when administered a single-dose to healthy male volunteers.
详细描述
Healthy volunteers are administrated single-dose over the period I and II (crossover) of SYO-1126 and Glivec Film Coated tab 4T (400mg) as of imatinib 400mg.
Every time before and after each medication, pharmacokinetic (PK) parameters and safety of SYO-1126 and Glivec Film Coated tab 4T (400mg) is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively.
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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Between 20aged and 45aged in healthy males
- •Over 55kg and BMI: 18.5~25 kg/m2
- •Agreement with written informed consent
排除标准
- •Subject with symptoms of acute disease at the time of screening
- •Clinically significant cardiovascular system, pulmonary system, renal system, endocrine system, blood system, gastrointestinal system, nervous system, mental disease or malignant tumor
- •Subject with known for gastrointestinal disease or surgical history which affect on absorption of drug
- •An impossible one who participates in clinical trial by result of screening tests
- •Inadequate result of laboratory test AST/ALT > 1.5 x UNL Total bilirubin > 1.5 X UNL
- •Clinically significant allergic disease(Except for mild allergic rhinitis seems to be not need for medication)
- •Subject with known for hypersensitivity reaction to imatinib analog
- •Subject with known for history which drug abuse or show positive for it in screening tests
- •Previously participate in other trial within 60 days
- •Previously make whole blood donation within 60 days or component blood donation within 30 days
- •Previously have blood transfusion within 30 days
- •Not able to taking the institutional standard meal
- •Subject who have had abnormal eating which affect on the ADME of drug
- •Not able to taking the grapefruit-containing foods
- •Taking ETC(ethical the counter)medicine including oriental medicine within 14 days or taking OTC(over the counter)medicine or vitamin preparations within 7 days
- •Continued to be taking caffein(caffein>5cup/day), drinking (alcohol>30g/day) and severe heavy smoker(cigarette>1/2pack/day)
- •An impossible one who participates in clinical trial by investigator's decision including for reason laboratory test result
研究组 & 干预措施
SYO-1126
Imatinib 400mg/tablet, PO, 1 tablet once daily for I&II D1(crossover)
干预措施: SYO-1126 (Drug)
Glivec film coated tab 4T(400mg)
100mg/tablet, po, 4 tablets once daily for period I&II D1(crossover)
干预措施: Glivec film coated tab 4T(400mg) (Drug)
结局指标
主要结局
Pharmacokinetics of the AUCt SYO-1126 anf Glivec Film coated tab 4T(400mg)
时间窗: 0-72hr
Pharmacokinetics of the Cmax SYO-1126 anf Glivec Film coated tab 4T(400mg)
时间窗: 0-72hr
次要结局
- Pharmacokinetics of the Tmax of SYO-1126 and Glivec Film Coated 4T(400mg)(0-72hr)
- Pharmacokinetics of the AUCinf SYO-1126 and Glivec Film Coated 4T(400mg)(0-72hr)
- Evaluation of the safety of SYO-1126 and Glivec Film Coated 4T(400mg) from vital signs, physical exam, ECG, laboratory test, adverse events and so on.(20~24 days)
- Pharmacokinetics of the T1/2 of SYO-1126 and Glivec Film Coated 4T(400mg)(0-72hr)
- Pharmacokinetics of the CL/F of SYO-1126 and Glivec Film Coated 4T(400mg)(0-72hr)