[Translation] Bioequivalence study of voriconazole for injection in humans under fasting conditions
考察健康受试者在空腹条件下,单次注射由湖南赛隆药业有限公司生产的注射用伏立康唑(受试制剂T,规格:200mg)与单次注射由Pfizer Europe MA EEIG持证的注射用伏立康唑(参比制剂R,商品名:Vfend®,规格:200mg)的药动学特征,评价两制剂的生物等效性和安全性,为该受试制剂注册申请提供依据。
[Translation] To investigate the pharmacokinetic characteristics of a single injection of voriconazole for injection (test preparation T, strength: 200 mg) produced by Hunan Sailon Pharmaceutical Co., Ltd. and a single injection of voriconazole for injection certified by Pfizer Europe MA EEIG (reference preparation R, trade name: Vfend®, strength: 200 mg) in healthy subjects under fasting conditions, evaluate the bioequivalence and safety of the two preparations, and provide a basis for the registration application of the test preparation.
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