[Translation] A randomized, open-label, single-dose, two-formulation, two-period crossover, fasting bioequivalence study of voriconazole for injection in healthy subjects
主要研究目的:研究空腹状态下单次静脉滴注给予受试制剂注射用伏立康唑(规格:0.2 g,重庆药友制药有限责任公司生产,北京吉洛华制药有限公司持证)与参比制剂注射用伏立康唑(威凡®,规格:0.2 g,Pharmacia & Upjohn Company LLC生产,Pfizer Europe MA EEIG持证)在健康受试者体内的药代动力学,评价两种制剂的生物等效性。
次要研究目的:评估受试制剂注射用伏立康唑(规格:0.2 g)和参比制剂注射用伏立康唑(威凡®,规格:0.2 g)在健康受试者中的安全性。
[Translation] Primary study objective: To study the pharmacokinetics of the test preparation voriconazole injection (specification: 0.2 g, produced by Chongqing Yaoyou Pharmaceutical Co., Ltd., licensed by Beijing Jiluohua Pharmaceutical Co., Ltd.) and the reference preparation voriconazole injection (Weifan®, specification: 0.2 g, produced by Pharmacia & Upjohn Company LLC, licensed by Pfizer Europe MA EEIG) in healthy subjects after a single intravenous infusion under fasting conditions, and to evaluate the bioequivalence of the two preparations.
Secondary study objective: To evaluate the safety of the test preparation voriconazole injection (specification: 0.2 g) and the reference preparation voriconazole injection (Weifan®, specification: 0.2 g) in healthy subjects.