The purpose of this study is to evaluate the pharmacokinetic properties and safety of SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
SYP-1018 200mg, Intravenous administration
Voriconazole 200mg, Intravenous administration
Clinical Research Institute, Seoul National University Hospital
Seoul, South Korea
Pharmacokinetics parameters
AUClast, Cmax
Time frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h
Pharmacokinetics parameters
AUCinf, Tmax, T1/2, CL
Time frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h
Safety
Adverse events, Laboratory assessments, Vital signs, Electrocardiograms(ECGs)
Time frame: 16 days
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