[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study evaluating the investigational formulation utpatinib extended-release tablets (15 mg) and the reference formulation utpatinib extended-release tablets (Refo®, 15 mg) in healthy adult participants under fasting and postprandial 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;山东诺禾康药业有限公司生产)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)在健康成年参与者体内的药代动力学,评价空腹和餐后状态下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)在健康参与者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetics of a single oral dose of the test formulation utpatinib extended-release tablets (15 mg; manufactured by Shandong Novogene Pharmaceutical Co., Ltd.) and the reference formulation utpatinib extended-release tablets (Reif®; 15 mg; manufactured by AbbVie Ireland NL B.V.) in healthy adult participants under fasting and postprandial conditions, and to evaluate the bioequivalence of the two formulations under fasting and postprandial conditions.
Secondary objective: To evaluate the safety of the test formulation utpatinib extended-release tablets (15 mg) and the reference formulation utpatinib extended-release tablets (Reif®, 15 mg) in healthy participants.