[Translation] A single-center, randomized, open-label, two-dose, fasting and fed, single-dose, 2-sequence, 4-period, repeated crossover bioequivalence study of edoxaban tosylate tablets developed by Jiangsu Huayang Pharmaceutical Co., Ltd. and Risenan® marketed by Daiichi Sankyo Europe GmbH in healthy subjects
以江苏华阳制药有限公司生产的甲苯磺酸艾多沙班片(30 mg)为受试制剂,以Daiichi Sankyo Europe GmbH上市的里先安®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] Edoxaban tosylate tablets (30 mg) produced by Jiangsu Huayang Pharmaceutical Co., Ltd. were used as the test preparation, and Risenan® marketed by Daiichi Sankyo Europe GmbH 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. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.