[Translation] A single-center, randomized, open-label, single-dose, fasting/fed, two-dose, two-period, double-crossover bioequivalence study to evaluate vonoprazan fumarate tablets in healthy Chinese adult subjects
以Takeda Pharmaceutical Company Limited为持证商的富马酸伏诺拉生片(商品名:Vocinti®/沃克®,规格:20mg)为参比制剂,中曦(福建)药业有限公司持证的富马酸伏诺拉生片(规格:20mg)为受试制剂,评价两种制剂在空腹/餐后状态下在中国成年健康受试者中的生物等效性。同时评价空腹/餐后状态下受试制剂和参比制剂在中国成年健康受试者中的安全性。
[Translation] The reference preparation was vonoprazan fumarate tablets (trade name: Vocinti®/Walker®, specification: 20 mg) licensed by Takeda Pharmaceutical Company Limited, and the test preparation was vonoprazan fumarate tablets (specification: 20 mg) licensed by Zhongxi (Fujian) Pharmaceutical Co., Ltd. The bioequivalence of the two preparations in Chinese healthy adult subjects in the fasting/postprandial state was evaluated. At the same time, the safety of the test preparation and the reference preparation in Chinese healthy adult subjects in the fasting/postprandial state was evaluated.