[Translation] A single-dose, randomized, open-label, two-dose, four-period, two-sequence, completely repeated crossover, fasting bioequivalence study of sorafenib tosylate tablets in healthy Chinese subjects
主要目的:以广州白云山医药集团股份有限公司白云山制药总厂生产的甲苯磺酸索拉非尼片(规格:0.2g)为受试制剂,与原研单位Bayer AG持证的甲苯磺酸索拉非尼片(商品名:多吉美®;规格:0.2g)为参比制剂,评估受试制剂和参比制剂在空腹条件下的生物等效性。次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of the test preparation and the reference preparation under fasting conditions, using Sorafenib Tosylate Tablets (Specification: 0.2g) produced by Baiyunshan Pharmaceutical General Factory of Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. as the test preparation and Sorafenib Tosylate Tablets (Trade name: Nexavar®; Specification: 0.2g) certified by the original research unit Bayer AG as the reference preparation. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.