[Translation] A single-center, randomized, open-label, single-dose, two-formulation, four-period, two-sequence complete repeat crossover fasting bioequivalence study of bilastine tablets in healthy volunteers
本试验旨在研究单次空腹口服北京四环科宝制药股份有限公司研制、生产的比拉斯汀片(20 mg)的药代动力学特征;以Faes Farma, S.A.生产的比拉斯汀片(Bilaxten®,20 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] The purpose of this experiment is to study the pharmacokinetic characteristics of bilastine tablets (20 mg) developed and produced by Beijing Sihuan Kebao Pharmaceutical Co., Ltd. after a single oral administration on an empty stomach; bilastine tablets produced by Faes Farma, S.A. (Bilaxten®, 20 mg) was used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the human bioequivalence of the two preparations.