[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, two-cycle, double-crossover, fasting bioequivalence study of bilastine tablets in healthy subjects
主要研究目的:以 Menarini International Operations Luxembourg S.A.持证的比拉斯汀片(商品名:ILAXTEN,20 mg)为参比制剂,以江苏东科康德药业有限公司持有的比拉斯汀片为受试制剂,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条件下的人体生物等效性。
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 bilastine tablets (trade name: ILAXTEN, 20 mg) licensed by Menarini International Operations Luxembourg S.A. as the reference preparation and the bilastine tablets held by Jiangsu Dongke Kangde Pharmaceutical Co., Ltd. as the test preparation, and to evaluate the bioequivalence of the two preparations under fasting conditions through a single-center, randomized, open, single-dose, two-preparation, two-sequence, two-cycle, 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.