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

Samyang Biopharmaceuticals Corporation

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: SYO-1126

Drug: Glivec film coated tab 4T(400mg)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01504984

SYO1126

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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