Seoul National University Hospital
Seoul, South Korea
NCT Number: NCT03674060
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.
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Notify Me19 year–50 year
Male
Interventional
Phase 1
Seoul, South Korea
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: SYO-1644 100, 150, 200mg
Nexavar 200mg/tablet, PO, 1 tablet
Other names: Sorafenib 200mg
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168 hours
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
Pharmacokinetics of the Cmax between SYO-1644 and Nexavar cap(200mg)
Samyang Biopharmaceuticals Corporation
Industry
A Dose-block Randomized, Active-controlled, Open-label Clinical Study to Compare Pharmacokinetic Property of SYO-1644 Tab and Nexavar Tab in Healthy Male Volunteers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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