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

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

Timeline

Start

2015-09

Primary completion

2015-10

Completion

2015-11

Outcome

Met primary endpoint

paper Equivalent pharmacokinetic characteristics that satisfied the criteria of bioequivalence and similar safety profiles were observed for both test and reference formulations. PMID 32468741 ↗

Publications

• Cho SH, Kim CW, Nam MS. Pharmacokinetics and Safety of Two Voriconazole Formulations after Intravenous Infusion in Healthy Korean Volunteers. Infect Chemother. 2020 Jun;52(2):204-211. doi: 10.3947/ic.2020.52.2.204. Epub 2020 May 29.

Drugs

Indications