期刊论文

Bioequivalence of rivaroxaban tablets in healthy Chinese Volunteers

中文

中国临床药理学杂志

1001-6821

2019

35

24

3223-3226

10.13699/j.cnki.1001-6821.2019.24.013

本校为第一机构

目的评价利伐沙班片在中国健康受试者的生物等效性。方法采用随机、开放、两制剂、空腹及餐后、单次给药、两序列、四周期、完全重复、交叉设计。空腹及餐后试验各入组26例健康受试者,随机分为2组,每周期单次空腹或餐后口服受试制剂或参比制剂10 mg。采用HPLC - MS /MS法测定给药后不同时间点利伐沙班的血药浓度。采用Phoenix WinNonlin 7.0软件按非房室模型计算药代动力学参数,并进行生物等效性评价。结果受试者单次空腹口服利伐沙班受试制剂和参比制剂10 mg后的药动学参数如下: C_(max)分别为( 159.25±54.53), ( 162.77±53.67) ng·mL~(-1); AUC_(0 - t)分别为( 1106.21±431.51) L和( 1086...

Objective To evaluate the bioequivalence of the two rivaroxaban tablets in Chinese healthy volunteers. Methods A single - dose,randomized,open - label,two - sequence,four - period,fully repetitive,crossover study was conducted in healthy subjects. 26 participants were administered test and reference rivaroxaban tablets ( 10 mg) under fasting and fed condition respectively. The concentrations of rivaroxaban in plasma were determined by HPLC - MS /MS. The pharmacokinetic parameters were calculated and the bioequivalence was compared by non - comp...