Crossover Study to Compare Pharmacokinetic Property of SYO-1126 and Glivec Film Coated Tab in Healthy Male Volunteers

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.

Inclusion criteria

• Between 20aged and 45aged in healthy males
• Over 55kg and BMI: 18.5~25 kg/m2
• Agreement with written informed consent

Exclusion criteria

• 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