[Translation] Vonoraphan fumarate tablets developed by Suzhou Sinochem Pharmaceutical Industry Co., Ltd. and the original reference preparation have been approved by Chinese health authorities.
Single-center, randomized, open-label, two-preparation, fasting and postprandial, single-dose, two-cycle, double-dose study in subjects
Bioequivalence studies in crossover designs
以苏州中化药品工业有限公司研制的富马酸伏诺拉生片(规格:20 mg)为受试制剂,生产厂为Takeda Pharmaceutical Company Limited的富马酸伏诺拉生片(商品名:沃克®/Vocinti®,规格:20 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。同时评价两种制剂在健康人体中的安全性和耐受性。
[Translation] Vonoraphan fumarate tablets (specification: 20 mg) developed by Suzhou Sinochem Pharmaceutical Industry Co., Ltd. were used as the test preparation. The manufacturer was Takeda Pharmaceutical Company Limited’s vonoraphanate tablets (trade name: Walker ®/Vocinti®, specification: 20 mg) is a reference preparation. The pharmacokinetic parameters and relative bioavailability of a single dose of the two preparations under fasting and postprandial conditions are examined to evaluate whether the two preparations are bioequivalent. . The safety and tolerability of both formulations in healthy humans were also evaluated.