[Translation] A single-center, randomized, open-label, two-dose, fasting and fed, single-dose, two-period, double-crossover bioequivalence study of posaconazole enteric-coated tablets from Kangyuan Huawei Pharmaceutical Co., Ltd. and posaconazole enteric-coated tablets from Merck Sharp & Dohme Ltd (trade name: Nocofil®) in healthy Chinese subjects
以康缘华威医药有限公司的泊沙康唑肠溶片(100 mg)为受试制剂,Merck Sharp & Dohme Ltd上市的诺科飞®(NOXAFIL®,规格100 mg)为参比制剂,考察两制剂在空腹及餐后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 enteric-coated tablets (100 mg) produced by Kangyuan Huawei Pharmaceuticals Co., Ltd. were used as the test preparation, and NOXAFIL® (100 mg) marketed by Merck Sharp & Dohme Ltd was used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent, and the safety of the two preparations in healthy subjects was evaluated.