[Translation] A randomized, open-label, two-formulation, single-dose, two-cycle, two-sequence, postprandial bioequivalence study of imatinib mesylate tablets in healthy subjects
主要目的:考察广州科锐特生物科技有限公司研制的受试制剂甲磺酸伊马替尼片(100mg)与Novartis Pharma Stein AG生产的参比制剂(格列卫®100mg)的相关药代动力学参数及相对生物利用度,评价两制剂的生物等效性,为广州科锐特生物科技有限公司研制的甲磺酸伊马替尼片的临床应用提供依据。
次要目的:观察两制剂在餐后条件下健康受试者中的安全性。
[Translation] Main purpose: To investigate the relevant pharmacokinetic parameters and relative bioavailability of the test preparation imatinib mesylate tablets (100 mg) developed by Guangzhou Core Biotechnology Co., Ltd. and the reference preparation (Gleevec® 100 mg) produced by Novartis Pharma Stein AG, evaluate the bioequivalence of the two preparations, and provide a basis for the clinical application of imatinib mesylate tablets developed by Guangzhou Core Biotechnology Co., Ltd.
Secondary purpose: To observe the safety of the two preparations in healthy subjects under postprandial conditions.