[Translation] Bioequivalence study of epinastine hydrochloride tablets in healthy participants in China, conducted in a single-center, randomized, open-label, single-dose, two-formulation, two-sequence, two-period, two-crossover, fasting and postprandial settings.
主要试验目的:以山西同达药业有限公司持有的盐酸依匹斯汀片为受试制剂,以Nippon Boehringer Ingelheim Co., Ltd.持证的盐酸依匹斯汀片(商品名:Alesion,20 mg)为参比制剂,通过单中心、随机、开放、单次给药、两制剂、两序列、两周期、双交叉临床试验来评价两种制剂在空腹和餐后条件下的人体生物等效性。
次要试验目的:观察受试制剂和参比制剂在中国健康研究参与者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of epinastine hydrochloride tablets (licensed by Shanxi Tongda Pharmaceutical Co., Ltd.) in humans under fasting and postprandial conditions through a single-center, randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover clinical trial, using epinastine hydrochloride tablets (trade name: Alesion, 20 mg) licensed by Nippon Boehringer Ingelheim Co., Ltd. as the reference formulation.
Secondary objective: To observe the safety of the test and reference formulations in Chinese health study participants.