[Translation] A randomized, open-label, two-period, single-dose, crossover bioequivalence study of entecavir tablets in healthy volunteers under fasting conditions
本研究以厦门德乐勤生物技术有限公司委托生产的恩替卡韦片(规格:以恩替卡韦计1 mg)为受试制剂,原研厂家中美上海施贵宝制药有限公司生产的恩替卡韦片(规格:以恩替卡韦计1 mg,商品名博路定)为参比制剂,评估受试制剂和参比制剂在空腹条件下给药的生物等效性。
[Translation] In this study, entecavir tablets (specification: 1 mg of entecavir) produced by Xiamen Deluqin Biotechnology Co., Ltd. were used as the test preparation, and entecavir tablets (specification: 1 mg of entecavir, trade name Boluding) produced by the original manufacturer Shanghai Bristol-Myers Squibb Pharmaceuticals Co., Ltd. were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation under fasting conditions.