[Translation] A randomized, open-label, two-dose, single-dose, two-period, double-crossover bioequivalence pilot study of voriconazole for injection in healthy subjects under fasting conditions
以陕西博森生物制药股份集团有限公司生产的注射用伏立康唑为受试制剂,以Pharmacia&Upjohn Company生产的注射用伏立康唑(商品名:威凡®)为参比制剂,考察空腹条件下静脉滴注注射用伏立康唑的药代动力学参数,验证血药浓度分析方法以及采血时间、采样量等的合理性,初步评价两种制剂的生物等效性结果和个体内变异系数。
[Translation] Voriconazole for injection produced by Shaanxi Bosen Biopharmaceutical Group Co., Ltd. was used as the test preparation, and voriconazole for injection produced by Pharmacia & Upjohn Company (trade name: Weifan®) was used as the reference preparation. The pharmacokinetic parameters of voriconazole for injection by intravenous drip under fasting conditions were investigated, the rationality of the blood drug concentration analysis method and the blood sampling time and sampling volume were verified, and the bioequivalence results and intra-individual coefficient of variation of the two preparations were preliminarily evaluated.