[Translation] A single-center, randomized, open-label, two-agent, single-dose, three-cycle, partially replicated crossover design of a human bioequivalence study of vonoprazan fumarate tablets
以杭州中美华东制药有限公司生产的20mg富马酸沃诺拉赞片为受试制剂,以武田药品工业株式会社生产的20mg富马酸沃诺拉赞片(商品名:Takecab®)为参比制剂,按生物等效性试验的相关规定,比较单次空腹和餐后条件下口服富马酸沃诺拉赞片在中国健康受试者体内的药代动力学行为,评价两者的生物等效性。
[Translation] The 20mg Vonorazan fumarate tablets produced by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. were used as the test preparation, and the 20mg Vonorazan Fumarate tablets (trade name: Takecab®) produced by Takeda Pharmaceutical Co. Compared with the preparation, according to the relevant provisions of the bioequivalence test, the pharmacokinetic behavior of oral vornorazan fumarate tablets in Chinese healthy subjects under a single fasting and postprandial condition was compared, and the biological effects of the two were evaluated. Equivalence.