[Translation] A single-center, randomized, open-label, two-agent, single-dose, two-cycle, double-crossover fasting bioequivalence trial of voriconazole for injection in healthy subjects
主要目的:以药代动力学参数作为主要终点评价指标,比较在空腹状态下给予受试制剂福安药业集团烟台只楚药业有限公司生产的注射用伏立康唑与参比制剂 Pfizer Europe MA EEIG公司持有的注射用伏立康唑(商品名:威凡®)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
次要目的:观察受试制剂注射用伏立康唑和参比制剂注射用伏立康唑在健康受试者中的安全性。
[Translation] Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, to compare the test preparation voriconazole for injection produced by Fuan Pharmaceutical Group Yantai Chichu Pharmaceutical Co., Ltd. and the reference preparation Pfizer Europe MA EEIG in fasting state. The pharmacokinetic behavior of voriconazole for injection (trade name: Weifan®) in healthy subjects was evaluated, and the bioequivalence of the two preparations was evaluated.
Secondary objective: To observe the safety of voriconazole for injection of the test preparation and voriconazole for injection of the reference preparation in healthy subjects.