[Translation] A single-center, open-label, randomized, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of a single oral dose of vonoprazan fumarate tablets in Chinese healthy volunteers under fasting and fed conditions
研究健康受试者空腹和餐后单次口服受试制剂富马酸伏诺拉生片(四川迪菲特药业有限公司,规格:20 mg)与参比制剂富马酸伏诺拉生片(商品名:沃克,Takeda Pharmaceutical Company Limited.,规格:20 mg)在吸收程度和速度方面是否存在差异,评价受试制剂和参比制剂在空腹及餐后条件下给药时的生物等效性,观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] To investigate whether there are differences in the extent and rate of absorption between the test preparation vonoprazan fumarate tablets (Sichuan Difit Pharmaceutical Co., Ltd., specification: 20 mg) and the reference preparation vonoprazan fumarate tablets (trade name: Walker, Takeda Pharmaceutical Company Limited., specification: 20 mg) taken orally on an empty stomach and after a meal in healthy subjects, to evaluate the bioequivalence of the test preparation and the reference preparation when administered on an empty stomach and after a meal, and to observe the safety of the test preparation and the reference preparation in healthy subjects.