[Translation] A randomized, open-label, single-dose, two-period, double-crossover, fasting and fed bioequivalence study of upadacitinib extended-release tablets (15 mg) produced by Jiuhua Huayuan Pharmaceutical (Guilin) Co., Ltd. and upadacitinib extended-release tablets (Rinvoq®/Rinvoq®, 15 mg) produced by ABBVIE DEUTSCHLAND GMBH & CO. KG in healthy Chinese subjects
以九华华源药业(桂林)有限公司生产的乌帕替尼缓释片(规格:15 mg)为受试制剂,以ABBVIE DEUTSCHLAND GMBH & CO. KG的乌帕替尼缓释片(Rinvoq®/瑞福®,规格:15 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;同时评价两种制剂在健康人体中的安全性和耐受性。
[Translation] Upadacitinib sustained-release tablets (specification: 15 mg) produced by Jiuhua Huayuan Pharmaceutical (Guilin) Co., Ltd. were used as the test preparation, and upadacitinib sustained-release tablets (Rinvoq®/Rinvoq®, specification: 15 mg) produced by ABBVIE DEUTSCHLAND GMBH & CO. KG were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent; at the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.