Conditions: Aspergillus Infections Candida Infections Fungal Infections
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

Brief summary:
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

Detailed description:
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.

Arms:
arm 1: Test drug: Vorico Injection 200mg(Voriconazole) Wash out: 7 days Reference drug: Vfend® IV 200mg arm 2: Reference drug: Vfend® IV 200mg Wash out: 7 days Test drug: Vorico Injection 200mg(Voriconazole)

Interventions: intervention 1: Vorico Injection 200mg(Voriconazole) intervention 2: Vfend®(Voriconazole) IV 200mg
Intervention descriptions: intervention 1: Vorico Injection 200mg(Voriconazole) to administered intravenously once intervention 2: Vfend®(Voriconazole) IV 200mg to administered intravenously once

Protocol document: