The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic characteristics between the Luckyvec 400mg tablet(x 1T) and Glivec 100mg(x 4T) when administered a single-dose to healthy volunteers.
Healthy volunteers are administrated single-dose over the period I and II (Crossover) of Luckyvec 400mg tablet(x 1T) and Glivec 100mg(x 4T)as of Imatinib 400mg. Every time before and after each medication, PK parameters and safety of Luckyvec 400mg tablet and Glivec 100mg is performed using a blood sample and conducting some tests(Laboratory test, V/S, Physical Examination, etc) respectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
•400mg/tablet, PO, 1 tablet once daily for Period I \& II D1(crossover)
•100mg/tablet, PO, 4 tablets once daily for Period I \& II D1(crossover)
The Korea University Anam Hospital
Seoul, South Korea
To evaluate the pharmacokinetics of Luckyvec 400mg tablet and Glivec 100mg tablet in healthy subjects
Time frame: 0-72hr
To evaluate the safety of Luckyvec 400mg tablet and Glivec 100mg tablet from vital signs, physical exam, ECG, laboratory test, adverse event and so on.
Time frame: 0-72hr
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