Comparative Study on Tolerance and Pharmacokinetics of Voriconazole for Injection in Healthy Subjects

Phase 1 Completed 48 enrolled The Affiliated Hospital of Qingdao University

RandomizedCrossoverOpen-labelOther

Summary

A single intravenous drip of voriconazole for injection developed by Qilu Pharmaceutical (Hainan) Co., Ltd. and the original product "vfend" was given to healthy subjects ， The pharmacokinetic differences and tolerance of the two preparations were evaluated at the doses of 4mg / kg and 6mg / kg.

Timeline

Start: 2020-05-22
Primary completion: 2020-07-08
Completion: 2020-09-16

Publications

Li X, Wang C, Shi P, Liu Y, Tao Y, Lin P, Li T, Hu H, Sun F, Liu S, Fu Y, Cao Y. Pharmacokinetics and safety of two Voriconazole formulations after intravenous infusion in two doses in healthy Chinese subjects. BMC Pharmacol Toxicol. 2023 Mar 3;24(1):14. doi: 10.1186/s40360-023-00652-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Voriconazole	Small molecule	4 mg/kg	Intravenous
Subject	Voriconazole	Small molecule	6 mg/kg	Intravenous

Indications

No indication recorded.