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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: SYO-1126
* Drug: Glivec film coated tab 4T(400mg)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYO-1126<br>Imatinib 400mg/tablet, PO, 1 tablet once daily for I&II D1(crossover) | Drug: SYO-1126<br>* Imatinib 400mg/tablet, PO, 1 tablet once daily for I&II D1(crossover)<br>* Other names: Imatinib 400mg;|
| Active Comparator: Glivec film coated tab 4T(400mg)<br>100mg/tablet, po, 4 tablets once daily for period I&II D1(crossover) | Drug: Glivec film coated tab 4T(400mg)<br>* Imatinib 100mg/tablet, PO, 4 tablets once daily for period I&II D1(crossover)<br>* Other names: Glivec film coated tab;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Evaluation of the pharmacokinetics equivalence, Healthy volunteers, Single dose over the period I and II(crossover), Healthy male volunteers