[Translation] A randomized, open-label, single-dose, two-sequence, two-period, two-crossover bioequivalence study of utpatinib extended-release tablets (15 mg) owned by Heilongjiang Fuhe Pharmaceutical Group Co., Ltd., and utpatinib extended-release tablets (Rinvoq®/瑞福®, 15 mg) owned by AbbVie Deutschland GmbH & Co. KG in healthy participants in China, under both fasting and postprandial conditions.
以黑龙江福和制药集团股份有限公司持有的乌帕替尼缓释片(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。
[Translation] Using utpatinib extended-release tablets (15 mg) from Heilongjiang Fuhe Pharmaceutical Group Co., Ltd. as the test formulation and utpatinib extended-release tablets (Rinvoq®/瑞福®, 15 mg) from AbbVie Deutschland GmbH & Co. KG as the reference formulation, the pharmacokinetic parameters and relative bioavailability of the two formulations under fasting and postprandial administration were investigated to evaluate whether the two formulations were bioequivalent; at the same time, the safety of the two formulations in healthy human subjects was evaluated.