[Translation] A single-center, open-label, randomized, single-dose, crossover bioequivalence study evaluating the test formulation baricitinib tablets (strength: 4 mg) versus the reference formulation baricitinib tablets (Olumiant®, strength: 4 mg) in healthy adult participants in the fasting and fed states
主要目的: 研究空腹和餐后状态下单次口服受试制剂巴瑞替尼片(规格:4 mg,生产厂家:山东朗诺制药有限公司)与参比制剂巴瑞替尼片(Olumiant®,规格:4 mg,生产厂家:Lilly S.A.)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。
次要目的:评估受试制剂巴瑞替尼片(规格:4 mg)和参比制剂巴瑞替尼片(Olumiant®,规格:4 mg)在健康参与者中的安全性。
[Translation] Primary objective: To study the pharmacokinetics of a single oral dose of the test preparation baricitinib tablets (specification: 4 mg, manufacturer: Shandong Langnuo Pharmaceutical Co., Ltd.) and the reference preparation baricitinib tablets (Olumiant®, specification: 4 mg, manufacturer: Lilly S.A.) in healthy adult participants in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state.
Secondary objective: To evaluate the safety of the test preparation baricitinib tablets (specification: 4 mg) and the reference preparation baricitinib tablets (Olumiant®, specification: 4 mg) in healthy participants.