[Translation] A single-dose, randomized, open-label, two-period, double-crossover, fasting bioequivalence study of afatinib maleate tablets (40 mg) developed by Jiangsu Kangbi Pharmaceutical Co., Ltd. and afatinib maleate tablets (trade name: GIOTRIF, 40 mg) certified by Boehringer Ingelheim International GmbH in healthy subjects
主要研究目的:以Boehringer Ingelheim International GmbH持证的马来酸阿法替尼片为参比制剂,以江苏康倍得药业股份有限公司研制的马来酸阿法替尼片为受试制剂,通过单中心、随机、开放、单次给药、两周期、双交叉的临床研究来评价两种制剂在空腹状态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 maleic acid afatinib tablets licensed by Boehringer Ingelheim International GmbH as the reference preparation and the maleic acid afatinib tablets developed by Jiangsu Kangbi Pharmaceutical Co., Ltd. as the test preparation to evaluate the bioequivalence of the two preparations in the fasting state through a single-center, randomized, open, single-dose, 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.