[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover, fasting and fed bioequivalence study of vonoprazan fumarate tablets (20 mg) in healthy subjects
主要研究目的:以江苏东科康德药业有限公司生产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,规格:20 mg,按C17H16FN3O2S计)为参比制剂,通过单中心、随机、开放、单次给药、两制剂、两序列、两周期、双交叉临床研究来评价两种制剂在空腹和餐后条件下的生物等效性。
次要研究目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to use the vonoprazan fumarate tablets produced by Jiangsu Dongke Kangde Pharmaceutical Co., Ltd. as the test preparation and the vonoprazan fumarate tablets (trade name: Walker, specification: 20 mg, calculated as C17H16FN3O2S) certified by Takeda Pharmaceutical Company Limited as the reference preparation. The bioequivalence of the two preparations under fasting and postprandial conditions is evaluated through a single-center, randomized, open, single-dose, two-preparation, two-sequence, two-period, double-crossover clinical study.
Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.