Phase I Clinical Trial for Comparison of Pharmacokinetic Characteristics of Vorico Injection 200mg(Voriconazole) and Vfend® IV 200mg for Single Dose Crossover Intravenous Infusion in Healthy Volunteers
To healthy volunteers subjects of twenty four(24), following treatments are administered dosing in each period injected wash-out period is a minimum of 7days. Treatment A(Test Drug): Vorico Injection 200mg(Voriconazole) for Single Dose Treatment B(Reference Drug): Vfend® IV 200mg for Single Dose Pharmacokinetic blood samples are collected up to 24hrs. Safety and pharmacokinetic are assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Vorico Injection 200mg(Voriconazole) to administered intravenously once
Vfend®(Voriconazole) IV 200mg to administered intravenously once
Inha University Hospital
Incheon, South Korea
Cmax of Voriconazole
The blood sampleing coleected from the subjects was analyzed and result was obtained.
Time frame: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
AUCt of Voriconazole
The blood sampleing coleected from the subjects was analyzed and result was obtained.
Time frame: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
Tmax of Voriconazole
The blood sampleing coleected from the subjects was analyzed and result was obtained.
Time frame: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
AUCinf of Voriconazole
The blood sampleing coleected from the subjects was analyzed and result was obtained.
Time frame: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
AUCt/AUCinf
The blood sampleing coleected from the subjects was analyzed and result was obtained.
Time frame: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
Kel (Elemination Rate Constant)
The blood sampleing coleected from the subjects was analyzed and result was obtained.
Time frame: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
t1/2
The blood sampleing coleected from the subjects was analyzed and result was obtained.
Time frame: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
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