[Translation] A single-center, randomized, open-label, two-period, double-crossover design to evaluate the bioequivalence of afatinib maleate tablets in Chinese healthy subjects after a single fasting oral administration
主要目的: 以 Boehringer Ingelheim International GmbH 原研进口的马来酸阿法替尼片(GIOTRIF®,40 mg)为参比制剂,以甘肃兰药药业有限公司生产的马来酸阿法替尼片(40 mg)为受试制剂,通过单中心、随机、开放、双周期、双交叉设计的临床试验评价两种制剂在空腹状态下的生物等效性。
次要目的: 评价受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: Using the imported afatinib maleate tablets (GIOTRIF®, 40 mg) originally developed by Boehringer Ingelheim International GmbH as the reference preparation and the afatinib maleate tablets (40 mg) produced by Gansu Lanyao Pharmaceutical Co., Ltd. as the test preparation, the bioequivalence of the two preparations in the fasting state was evaluated through a single-center, randomized, open, two-period, double-crossover clinical trial.
Secondary objective: To evaluate the safety of the test preparation and the reference preparation in healthy Chinese subjects.