[Translation] A randomized, open-label, two-period, self-crossover, single-dose design was used to evaluate the bioequivalence of tofacitinib citrate tablets in the fed state.
评估餐后状态下,单次口服枸橼酸托法替布片受试制剂(规格:5mg/片,杭州朱养心药业有限公司)与参比制剂枸橼酸托法替布片(尚杰®/Xeljanz®,规格:5mg/片,Pfizer Manufacturing Deutschland GmbH)在中国健康受试者体内的单次口服药动学特征,比较其相对生物利用度,初步评价餐后条件下两制剂间的生物等效性;2.探索采血点及清洗期设置,为正式试验设计提供参考依据。
[Translation] To evaluate the pharmacokinetic characteristics of a single oral dose of the test formulation of tofacitinib citrate tablets (specification: 5 mg/tablet, Hangzhou Zhuyangxin Pharmaceutical Co., Ltd.) and the reference formulation of tofacitinib citrate tablets (Shangjie®/Xeljanz®, specification: 5 mg/tablet, Pfizer Manufacturing Deutschland GmbH) in healthy Chinese subjects under fed conditions, compare their relative bioavailability, and preliminarily evaluate the bioequivalence between the two formulations under fed conditions; 2. Explore the setting of blood collection points and washout periods to provide a reference basis for the formal trial design.