[Translation] Protocol for a single-center, randomized, open-label, two-formulation, single-dose, two-period, double-crossover postprandial bioequivalence study of vonoprazan fumarate tablets in healthy subjects.
主要目的:以药代动力学参数作为主要终点评价指标,比较在餐后条件下口服受试制剂富马酸伏诺拉生片(规格:20mg,生产厂家:山东方明药业集团股份有限公司)与参比制剂富马酸伏诺拉生片(规格:20mg,持证商:Takeda Pharmaceutical Company Limited,商品名:沃克®)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
次要目的:观察受试制剂富马酸伏诺拉生片和参比制剂富马酸伏诺拉生片在健康受试者中的安全性。
[Translation] Primary Objective: To evaluate the bioequivalence of the test formulation vonoprazan fumarate tablets (20 mg, manufactured by Shandong Fangming Pharmaceutical Group Co., Ltd.) and the reference formulation vonoprazan fumarate tablets (20 mg, manufactured by Takeda Pharmaceutical Company Limited, trade name: Walker®) in healthy subjects after oral administration under postprandial conditions, using pharmacokinetic parameters as the primary endpoint.
Secondary Objective: To observe the safety of the test formulation vonoprazan fumarate tablets and the reference formulation vonoprazan fumarate tablets in healthy subjects.