[Translation] A single-center, randomized, open-label, two-formulation, fasting and postprandial, single-dose, two-period, double-crossover bioequivalence study of ruxolitinib phosphate tablets in healthy Chinese subjects.
主要目的:以新天地药业股份有限公司持有的磷酸芦可替尼片(规格:20 mg)为受试制剂,持证商为Novartis Europharm Limited的磷酸芦可替尼片(商品名:Jakavi,规格:20 mg)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。次要目的:评价磷酸芦可替尼片(规格:20 mg)受试制剂及参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic parameters and relative bioavailability of ruxolitinib phosphate tablets (20 mg) manufactured by Xintiandi Pharmaceutical Co., Ltd., as the test formulation, and ruxolitinib phosphate tablets (Jakavi, 20 mg) manufactured by Novartis Europharm Limited, as the reference formulation, under fasting and postprandial administration, and to evaluate the bioequivalence of the two formulations. Secondary objective: To evaluate the safety of ruxolitinib phosphate tablets (20 mg) in healthy Chinese subjects.