Healthy
Conditions
Keywords
Evaluation of the pharmacokinetics equivalence, Healthy volunteers, Single dose over the period I and II(crossover), Healthy male volunteers
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.
Interventions
DRUGSYO-1126
Imatinib 400mg/tablet, PO, 1 tablet once daily for I&II D1(crossover)
DRUGGlivec film coated tab 4T(400mg)
Imatinib 100mg/tablet, PO, 4 tablets once daily for period I&II D1(crossover)
Sponsors
Severance Hospital
Samyang Biopharmaceuticals Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Pharmacokinetics of the CL/F 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 |
| 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 |
Countries
South Korea
Outcome results
None listed