[Translation] A randomized, open-label, two-dose, single-dose, two-period, double-crossover bioequivalence study of vonoprazan fumarate tablets in healthy subjects under fasting and fed conditions
主要目的:以陕西西岳制药有限公司研制的富马酸伏诺拉生片为受试制剂,以Takeda Pharmaceutical Company Limited持证的富马酸伏诺拉生片(商品名:沃克®)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。
次要目的:评价中国健康受试者单次空腹/餐后口服富马酸伏诺拉生片受试制剂和参比制剂后的安全性。
[Translation] Primary objective: To use the vonoprazan fumarate tablets developed by Shaanxi Xiyue Pharmaceutical Co., Ltd. as the test preparation and the vonoprazan fumarate tablets (trade name: Walker®) certified by Takeda Pharmaceutical Company Limited as the reference preparation, to investigate the pharmacokinetic parameters and relative bioavailability of the two preparations in the fasting and postprandial state after a single administration, and to evaluate whether the two preparations are bioequivalent.
Secondary objective: To evaluate the safety of the test and reference preparations of vonoprazan fumarate tablets after a single oral administration on an empty stomach/postprandial basis in healthy Chinese subjects.