[Translation] A single-center, randomized trial of posaconazole injection produced by Hainan Hailing Chemical Pharmaceutical Co., Ltd. and posaconazole injection produced by MERCK SHARP DOHME (trade name: Noxafil®) in Chinese healthy subjects , open, two-drug, fasting, single-dose, two-period, double-crossover design bioequivalence study.
以海南海灵化学制药有限公司生产的泊沙康唑注射液(规格:16.7 mL:300 mg)为受试制剂,持证商为MERCK SHARP DOHME的泊沙康唑注射液(商品名:Noxafil ®,规格:16.7 mL:300 mg)为参比制剂,考察两制剂在空腹状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性,同时评价两制剂在健康受试者中的安全性。
[Translation] Posaconazole injection (specification: 16.7 mL: 300 mg) produced by Hainan Hailing Chemical Pharmaceutical Co., Ltd. was used as the test preparation, and the certificate holder was posaconazole injection (trade name: Noxafil ® ) of MERCK SHARP DOHME , specification: 16.7 mL: 300 mg) as the reference preparation, investigate the pharmacokinetic parameters and relative bioavailability of the two preparations in a single administration under fasting conditions, evaluate whether the two preparations have bioequivalence, and evaluate the two preparations at the same time Safety of the formulation in healthy subjects.