注射用伏立康唑在健康受试者中随机、开放、两制剂、单次给药、两周期、双交叉空腹状态下的生物等效性试验
[Translation] Bioequivalence study of voriconazole for injection in healthy subjects under randomized, open-label, two-dose, single-dose, two-period, double-crossover fasting state
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,考察两制剂的药代动力学参数及相对生物利用度,对两制剂进行生物等效性评价。
[Translation] Taking voriconazole for injection produced by Shaanxi Bosen Biopharmaceutical Co., Ltd. as the test preparation and voriconazole for injection (trade name: Weifan®) produced by Pharmacia & Upjohn Company as the reference preparation, the pharmacokinetics of the two preparations were investigated The parameters and relative bioavailability were used to evaluate the bioequivalence of the two preparations.
注射用伏立康唑在健康受试者中随机、开放、两制剂、单次给药、两周期、双交叉空腹状态下的生物等效性预试验
[Translation] A randomized, open-label, two-dose, single-dose, two-cycle, double-crossover fasting bioequivalence pilot trial of voriconazole for injection in healthy subjects
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] Taking voriconazole for injection produced by Shaanxi Bosen Biopharmaceutical Co., Ltd. as the test preparation, and taking voriconazole for injection (trade name: Weifan®) produced by Pharmacia & Upjohn Company as the reference preparation, the intravenous drip injection under fasting conditions was investigated. The pharmacokinetic parameters of voriconazole were used to verify the rationality of the blood concentration analysis method, blood collection time and sampling volume, and the bioequivalence results and intra-individual coefficient of variation of the two preparations were preliminarily evaluated.
100 Clinical Results associated with Shaanxi Bosen Biopharmaceutical Co., Ltd.
0 Patents (Medical) associated with Shaanxi Bosen Biopharmaceutical Co., Ltd.
100 Deals associated with Shaanxi Bosen Biopharmaceutical Co., Ltd.
100 Translational Medicine associated with Shaanxi Bosen Biopharmaceutical Co., Ltd.