[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study of baricitinib tablets in healthy adult participants under fasting conditions.
主要研究目的:以辰欣药业股份有限公司研制的巴瑞替尼片(规格:4 mg)为受试制剂,以日本イーライリリー株式会社持证的巴瑞替尼片(商品名:オルミエント®Olumiant®,规格:4 mg)为参比制剂,评估健康参与者体内的药代动力学,评价空腹状态口服两种制剂的生物等效性。
次要研究目的:评价中国健康参与者单次空腹状态下口服巴瑞替尼片受试制剂和参比制剂后的安全性。
[Translation] Primary objective: To evaluate the pharmacokinetics of baricitinib tablets (4 mg, developed by Chenxin Pharmaceutical Co., Ltd.) in healthy participants and assess the bioequivalence of the two formulations after oral administration in a fasting state, using baricitinib tablets (trade name: Olumiant®, 4 mg, certified by Irilyry Co., Ltd., Japan) as the test formulation.
Secondary objective: To evaluate the safety of a single oral administration of the test and reference formulations of baricitinib tablets in healthy Chinese participants in a fasting state.