The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by comparing pharmacokinetics characteristics between the SYP-1512 Tab and Revlimid cap (25mg) when administered a single-dose to healthy male volunteers.
Healthy volunteers are administrated single-dose over the period I and II (crossover) of SYP-1512 Tab and Revlimid cap (25mg) as of lenalidomide 25mg. Every time before and after each medication, pharmacokinetic (PK) parameters and safety of SYP-1512 Tab and Revlimid cap (25mg) 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
42
Lenalidomide 25mg/tablet, PO, 1 tablet once daily for I\&II D1(crossover)
Lenalidomide 25mg/capsule, po, 1 capsule once daily for period I\&II D1(crossover)
Pharmacokinetics of the AUCt between SYP-1512 and Revlimid cap(25mg)
Bioequivalance of the AUCt between SYP-1512 and Revlimid cap(25mg)
Time frame: 0-24hours
Pharmacokinetics of the Cmax between SYP-1512 and Revlimid cap(25mg)
Bioequivalance of the Cmax between SYP-1512 and Revlimid cap(25mg)
Time frame: 0-24hours
Pharmacokinetics of the AUCinf SYP-1512 and Revlimid cap (25mg)
Bioequivalance of the AUCinf SYP-1512 and Revlimid cap (25mg)
Time frame: 0-inf
Pharmacokinetics of the Tmax of SYP-1512 and Revlimid cap (25mg)
Bioequivalance of the Tmax of SYP-1512 and Revlimid cap (25mg)
Time frame: 0-24hours
Pharmacokinetics of the T1/2 of SYP-1512 and Revlimid cap (25mg)
Bioequivalance of the T1/2 of SYP-1512 and Revlimid cap (25mg)
Time frame: 0-24hours
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