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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Imatinib 400mg/tablet, PO, 1 tablet once daily for I\&II D1(crossover)
Imatinib 100mg/tablet, PO, 4 tablets once daily for period I\&II D1(crossover)
Severance hospital
Seoul, Seodaemun-gu, South Korea
Pharmacokinetics of the AUCt SYO-1126 anf Glivec Film coated tab 4T(400mg)
Time frame: 0-72hr
Pharmacokinetics of the Cmax SYO-1126 anf Glivec Film coated tab 4T(400mg)
Time frame: 0-72hr
Pharmacokinetics of the AUCinf SYO-1126 and Glivec Film Coated 4T(400mg)
Time frame: 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.
Time frame: 20~24 days
Pharmacokinetics of the Tmax of SYO-1126 and Glivec Film Coated 4T(400mg)
Time frame: 0-72hr
Pharmacokinetics of the T1/2 of SYO-1126 and Glivec Film Coated 4T(400mg)
Time frame: 0-72hr
Pharmacokinetics of the CL/F of SYO-1126 and Glivec Film Coated 4T(400mg)
Time frame: 0-72hr
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