[Translation] A randomized, open-label, two-cycle, self-crossover, single-dose design to evaluate the bioequivalence of tofacitinib citrate tablets in the postprandial 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] In the postprandial state, a single oral dose of the test preparation (specification: 5 mg/tablet, Hangzhou Zhuyangxin Pharmaceutical Co., Ltd.) and the reference preparation tofacitinib citrate tablets (Shangjie® /Xeljanz®, strength: 5mg/tablet, Pfizer Manufacturing Deutschland GmbH) single-dose oral pharmacokinetics in healthy Chinese subjects, compare its relative bioavailability, and preliminarily evaluate the biological effects between the two preparations under postprandial conditions, etc. 2. Explore the setting of blood collection points and cleaning period to provide reference for formal trial design.