[Translation] A single-dose, randomized, open-label, two-period, two-sequence, self-crossover bioequivalence study of vonoprazan fumarate tablets in healthy subjects under fasting and fed conditions
主要研究目的
研究空腹和餐后状态下单次口服受试制剂富马酸伏诺拉生片(规格:20mg,昆明源瑞制药有限公司)与参比制剂富马酸伏诺拉生片(商品名:沃克®,规格:20mg,Takeda Pharmaceutical Company Limited)在健康成年受试者体内的药代动力学,评价两制剂生物等效性。
次要研究目的
评价健康受试者空腹和餐后单次口服受试制剂(T)富马酸伏诺拉生片和参比制剂(R)富马酸伏诺拉生片(沃克®)后的安全性。
[Translation] Main study objectives
To study the pharmacokinetics of the test preparation Vonoprazan fumarate tablets (specification: 20 mg, Kunming Yuanrui Pharmaceutical Co., Ltd.) and the reference preparation Vonoprazan fumarate tablets (trade name: Walker®, specification: 20 mg, Takeda Pharmaceutical Company Limited) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations.
Secondary study objectives
To evaluate the safety of the test preparation (T) Vonoprazan fumarate tablets and the reference preparation (R) Vonoprazan fumarate tablets (Walker®) after a single oral administration in healthy subjects after fasting and feeding.