[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-cycle, double-crossover controlled bioequivalence study of upadacitinib extended-release tablets in healthy subjects under fasting and fed conditions
主要目的:研究空腹及餐后状态下单次口服受试制剂乌帕替尼缓释片(规格:15mg,山西泽辰医药科技有限公司持证)与参比制剂乌帕替尼缓释片(商品名:RINVOQ®/瑞福®,规格:15mg,持证商:AbbVie Deutschland GmbH & Co. KG)在健康成年受试者体内的药代动力学,评价空腹及餐后状态下口服两种制剂的生物等效性。
[Translation] Primary objective: To study the pharmacokinetics of the test formulation upadacitinib extended-release tablets (specification: 15 mg, licensed by Shanxi Zechen Pharmaceutical Technology Co., Ltd.) and the reference formulation upadacitinib extended-release tablets (trade name: RINVOQ®/Rinvoq®, specification: 15 mg, licensed by AbbVie Deutschland GmbH & Co. KG) in healthy adult subjects after a single oral dose in fasting and fed states, and to evaluate the bioequivalence of the two oral formulations in fasting and fed states.