[Translation] A single-center, randomized, open-label, single-dose, two-drug, four-cycle, two-sequence, completely repeated crossover, fasting bioequivalence study of axitinib tablets in healthy Chinese subjects
主要研究目的
本试验以金鸿药业股份有限公司生产的阿昔替尼片(规格:5mg)为受试制剂,以Pfizer Europe MA EEIG持证、Pfizer Manufacturing Deutschland GmbH生产的阿昔替尼片(商品名:英立达®/Inlyta®,规格:5mg)为参比制剂,考察空腹状态下受试制剂与参比制剂在健康受试者体内的药代动力学参数,评价两制剂的生物等效性。
次要研究目的
观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main study purpose
This study uses axitinib tablets (specification: 5 mg) produced by Jinhong Pharmaceutical Co., Ltd. as the test preparation, and axitinib tablets (trade name: Inlyta®/Inlyta®, specification: 5 mg) produced by Pfizer Europe MA EEIG and Pfizer Manufacturing Deutschland GmbH as the reference preparation to investigate the pharmacokinetic parameters of the test preparation and the reference preparation in healthy subjects under fasting conditions and evaluate the bioequivalence of the two preparations.
Secondary study purpose
To observe the safety of the test preparation and the reference preparation in healthy subjects.