[Translation] A randomized, open-label, two-dose, single-dose, two-period, double-crossover bioequivalence study of vonoprazan fumarate tablets in healthy study participants in the fasting and fed states
主要目的:以石家庄市普力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:评价中国健康研究参与者单次空腹/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 Shijiazhuang Puli Pharmaceutical Co., Ltd. as the test preparation and the vonoprazan fumarate tablets (trade name: Walker®) licensed 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 dose, 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 dose in the fasting/postprandial state in the participants of the China Health Study.