The purpose of this study is to evaluate the pharmacokinetics characteristics ,tolerability, and safety after orally administrating SYO-1644 to healthy male volunteers in randomized, active-controlled, open-label clinical study.
After orally administrating SYO-1644 and Nexavar 200 mg to healthy male participants , the safety, tolerability, and pharmacokinetic characteristics are to be compared while testing pharmacokinetic characteristics based on the dosage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
100mg: SYO-1644 tablet, PO, 1 100mg tablet 150mg: SYO-1644 tablet, PO, 1 100mg tablet and 1 50mg tablet 200mg: SYO-1644 tablet, PO, 2 100mg tablet
Nexavar 200mg/tablet, PO, 1 tablet
Seoul National University Hospital
Seoul, South Korea
Evaluation of pharmacokinetic properties
Pharmacokinetics of the AUCt between SYO-1644 and Nexavar cap(200mg)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168 hours
Evaluation of pharmacokinetic properties
Pharmacokinetics of the Cmax between SYO-1644 and Nexavar cap(200mg)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168 hours
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