[Translation] A randomized, open-label, two-formulation, single-dose, two-cycle, double-crossover bioequivalence study of utpatinib extended-release tablets in healthy participants in both fasting and postprandial states.
主要目的:以北大医药股份有限公司研制的乌帕替尼缓释片为受试制剂,以AbbVie Deutschland GmbH & Co. KG持有,AbbVie Ireland NL B.V.生产的乌帕替尼缓释片(商品名:瑞福®(RINVOQ®))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:评价中国健康参与者单次空腹及餐后口服乌帕替尼缓释片受试制剂和参比制剂后的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic parameters and relative bioavailability of utpatinib extended-release tablets (trade name: RINVOQ®) manufactured by AbbVie Ireland NL B.V. under fasting and postprandial conditions using utpatinib extended-release tablets developed by Peking University Medicine Co., Ltd. as the test formulation and RINVOQ® as the reference formulation, owned by AbbVie Deutschland GmbH & Co. KG.
Secondary objective: To evaluate the safety of single oral administration of utpatinib extended-release tablets (test and reference formulations) under fasting and postprandial conditions in healthy Chinese participants.