[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test formulation upadacitinib extended-release tablets (strength: 15 mg) and the reference formulation upadacitinib extended-release tablets (Rivum®, strength: 15 mg) in healthy adult subjects under fasting and fed conditions
主要研究目的:研究空腹和餐后状态下单次口服受试制剂乌帕替尼缓释片(规格:15 mg,杨凌科森生物制药有限责任公司生产)与参比制剂乌帕替尼缓释片(瑞福®,规格:15 mg,AbbVie Ireland NL B.V.生产)在健康受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
次要研究目的:评估受试制剂乌帕替尼缓释片(规格:15 mg)和参比制剂乌帕替尼缓释片(瑞福®,规格:15 mg)在健康受试者中的安全性。
[Translation] Primary study objectives: To study the pharmacokinetics of the test formulation upadacitinib extended-release tablets (specification: 15 mg, produced by Yangling Kesen Biopharmaceutical Co., Ltd.) and the reference formulation upadacitinib extended-release tablets (Rufu®, specification: 15 mg, produced by AbbVie Ireland NL B.V.) in healthy subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two formulations in the fasting and fed state.
Secondary study objectives: To evaluate the safety of the test formulation upadacitinib extended-release tablets (specification: 15 mg) and the reference formulation upadacitinib extended-release tablets (Rufu®, specification: 15 mg) in healthy subjects.