[Translation] A single-center, randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of bilastine orally disintegrating tablets (10 mg) developed by Zhuhai Huitongda Pharmaceutical Co., Ltd. and the original reference formulation (10 mg) in healthy Chinese subjects under fasting conditions
以珠海市汇通达医药有限公司研制的比拉斯汀口腔崩解片(规格:10 mg)为受试制剂,FAES FARMA, S.A生产的比拉斯汀口腔崩解片(商品名:Bilaxten®,规格:10 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。
[Translation] Bilastine orally disintegrating tablets (specification: 10 mg) developed by Zhuhai Huitongda Pharmaceutical Co., Ltd. were used as the test preparation, and Bilastine orally disintegrating tablets (trade name: Bilaxten®, specification: 10 mg) produced by FAES FARMA, S.A. were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration under fasting conditions were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety of the two preparations in healthy humans was evaluated.