[Translation] A single-center, randomized, open-label, two-sequence, four-period, crossover-design bioequivalence study of sorafenib tosylate tablets in Chinese healthy subjects after oral administration under fasting conditions
以仁合熙德隆药业有限公司生产的甲苯磺酸索拉非尼片(规格:0.2g)为受试制剂,持证商为拜尔公司的甲苯磺酸索拉非尼片(规格:0.2g,商品名:多吉美)为参比制剂,通过单中心、随机、开放、单次给药、两制剂、四周期的交叉设计来评价两种制剂空腹状态下的人体生物等效性。
[Translation] Sorafenib Tosylate Tablets (specification: 0.2g) produced by Renhe Xidelong Pharmaceutical Co., Ltd. was used as the test preparation, and Sorafenib Tosylate Tablets (specification: 0.2g, trade name: Nexavar) produced by Bayer AG was used as the reference preparation. A single-center, randomized, open, single-dose, two-preparation, four-period crossover design was used to evaluate the bioequivalence of the two preparations in the fasting state.