[Translation] A single-center, randomized, open-label, two-dose, single-dose, two-period, double-crossover, postprandial bioequivalence study of imatinib mesylate tablets in healthy subjects
主要目的:以药代动力学参数作为主要终点评价指标,比较在餐后状态下口服受试制剂甲磺酸伊马替尼片(规格:400mg,持证商:Hetero LabsLimited)与参比制剂甲磺酸伊马替尼片(规格:400mg,持证商:Novartis Pharmaceuticals Corporation)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
次要目的:观察受试制剂甲磺酸伊马替尼片和参比制剂甲磺酸伊马替尼片在健康受试者中的安全性。
[Translation] Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the pharmacokinetic behavior of the test preparation imatinib mesylate tablets (specification: 400 mg, licensee: Hetero Labs Limited) and the reference preparation imatinib mesylate tablets (specification: 400 mg, licensee: Novartis Pharmaceuticals Corporation) in healthy subjects after oral administration in the fed state, and evaluate the bioequivalence of the two preparations.
Secondary purpose: Observe the safety of the test preparation imatinib mesylate tablets and the reference preparation imatinib mesylate tablets in healthy subjects.