[Translation] A randomized, open-label, two-sequence, four-period, fully repeated crossover bioequivalence study of rivaroxaban tablets in Chinese healthy volunteers after single oral administration on an empty stomach or after a meal
研究空腹和餐后状态下单次口服利伐沙班片受试制剂(20mg,山东裕欣药业有限公司)与利伐沙班片参比制剂( 20mg,Xarelto®(拜瑞妥®), Bayer AG)后两种制剂是否具有生物等效性、利伐沙班的药代动力学特征和安全性。
[Translation] To investigate the bioequivalence, pharmacokinetic characteristics and safety of a single oral dose of a test formulation of rivaroxaban tablets (20 mg, Shandong Yuxin Pharmaceutical Co., Ltd.) and a reference formulation of rivaroxaban tablets (20 mg, Xarelto®, Bayer AG) in fasting and fed states.