[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence, double-crossover, fasting/fed bioequivalence study of vonoprazan fumarate tablets in Chinese healthy subjects
主要目的:评价中国健康受试者空腹、餐后状态下单次口服富马酸伏诺拉生片受试制剂(20 mg,山东裕欣药业有限公司)和参比制剂(20 mg,商品名:沃克®,Takeda Pharmaceutical Company Limited)后两种制剂是否具有生物等效性。 次要目的:评价中国健康受试者空腹、餐后状态下单次口服富马酸伏诺拉生片受试制剂和参比制剂后伏诺拉生的药代动力学特征、安全性。
[Translation] Primary objective: To evaluate the bioequivalence of the test formulation of vonoprazan fumarate tablets (20 mg, Shandong Yuxin Pharmaceutical Co., Ltd.) and the reference formulation (20 mg, trade name: Walker®, Takeda Pharmaceutical Company Limited) in Chinese healthy subjects after a single oral administration in the fasting and fed state. Secondary objective: To evaluate the pharmacokinetic characteristics and safety of vonoprazan after a single oral administration of the test formulation of vonoprazan fumarate tablets and the reference formulation in Chinese healthy subjects after a single oral administration in the fasting and fed state.