[Translation] Bilastine tablets (20 mg) produced by Jiangsu Yuexing Pharmaceutical Co., Ltd. and the original reference preparation (20 mg) were tested in a single-center, randomized, open-label, single-dose, two-cycle, double-dose trial in Chinese healthy subjects. Human bioequivalence study in cross-fasting state
以江苏悦兴药业有限公司生产的比拉斯汀片(规格:20 mg)为受试制剂,FAES FARMA, S.A生产的比拉斯汀片(商品名:BILAXTEN,规格:20 mg)为参比制剂,考察两制剂在空腹状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性。
[Translation] Bilastine tablets (specification: 20 mg) produced by Jiangsu Yuexing Pharmaceutical Co., Ltd. were used as the test preparation, and bilastine tablets (trade name: BILAXTEN, specification: 20 mg) produced by FAES FARMA, S.A were used as reference preparations. Compare the preparations, examine the pharmacokinetic parameters and relative bioavailability of the two preparations under a single administration in the fasting state, and evaluate whether the two preparations are bioequivalent. The safety and tolerability of both formulations in healthy humans were also evaluated.