注射用伏立康唑(0.2g)在中国健康成人中单次/多次给药的药代动力学和安全性试验以及单次给药的人体生物等效性试验
[Translation] Pharmacokinetics and safety studies of single/multiple doses of voriconazole for injection (0.2 g) in healthy Chinese adults and a single dose bioequivalence study in humans
以健康受试者为试验对象,天津力生制药股份有限公司研发的注射用伏立康唑(0.2g)为受试制剂,持证商为Pfizer Europe MA EEIG的注射用伏立康唑(商品名:威凡,规格:0.2g)为参比制剂;
经单次给药试验和多次给药试验:
1) 比较单次和多次给药后受试制剂和参比制剂药代动力学参数;
2) 观察受试制剂和参比制剂在中国健康受试者中的安全性。
经生物等效性试验:
1) 评价两种制剂在中国健康受试者中的生物等效性;
2) 观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Healthy subjects were used as test subjects, voriconazole for injection (0.2g) developed by Tianjin Lisheng Pharmaceutical Co., Ltd. was used as the test preparation, and voriconazole for injection (trade name: Weifan, specification: 0.2g) licensed by Pfizer Europe MA EEIG was used as the reference preparation;
After single-dose and multiple-dose tests:
1) Compare the pharmacokinetic parameters of the test preparation and the reference preparation after single and multiple administrations;
2) Observe the safety of the test preparation and the reference preparation in Chinese healthy subjects.
After bioequivalence test:
1) Evaluate the bioequivalence of the two preparations in Chinese healthy subjects;
2) Observe the safety of the test preparation and the reference preparation in Chinese healthy subjects.
100 Clinical Results associated with Tianjin Biochemical Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Tianjin Biochemical Pharmaceutical Co. Ltd.
100 Deals associated with Tianjin Biochemical Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Tianjin Biochemical Pharmaceutical Co. Ltd.