Crossover Study to Compare Pharmacokinetic Property of SYO-1126 and Glivec Film Coated Tab in Healthy Male Volunteers
- Registration Number
- NCT01504984
- Lead Sponsor
- Samyang Biopharmaceuticals Corporation
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description SYO-1126 SYO-1126 Imatinib 400mg/tablet, PO, 1 tablet once daily for I\&II D1(crossover) Glivec film coated tab 4T(400mg) Glivec film coated tab 4T(400mg) 100mg/tablet, po, 4 tablets once daily for period I\&II D1(crossover)
- Primary Outcome Measures
Name Time Method Pharmacokinetics of the AUCt SYO-1126 anf Glivec Film coated tab 4T(400mg) 0-72hr Pharmacokinetics of the Cmax SYO-1126 anf Glivec Film coated tab 4T(400mg) 0-72hr
- Secondary Outcome Measures
Name Time Method 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 Tmax of SYO-1126 and Glivec Film Coated 4T(400mg) 0-72hr 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
Trial Locations
- Locations (1)
Severance hospital
🇰🇷Seoul, Seodaemun-gu, Korea, Republic of