NCT02631954

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Aspergillus Infections
• Candida Infections
• Fungal Infections

Interventions

Type	Name	Description
DRUG	Vorico Injection 200mg(Voriconazole)	Vorico Injection 200mg(Voriconazole) to administered intravenously once
DRUG	Vfend®(Voriconazole) IV 200mg	Vfend®(Voriconazole) IV 200mg to administered intravenously once

Timeline

• Start date: 2015-09-01
• Primary completion: 2015-10-01
• Completion: 2015-11-01
• First posted: 2015-12-16
• Last updated: 2020-03-18
• Results posted: 2020-03-18

Locations

1 site across 1 country: South Korea