中国临床药理学杂志2024，Vol.40Issue(15)：2236-2240,5.DOI:10.13699/j.cnki.1001-6821.2024.15.018
吡嗪酰胺片在中国健康受试者中的生物等效性研究
Bioequivalence study of pyrazinamide tablets in Chinese healthy subjects
摘要
Abstract
Objective To evaluate the bioequivalence and safety of two pyrazinamide tablets in healthy Chinese subjects.Methods An open,randomized,single-dose,two-sequence,two-cycle,double-cross trial design was used.All 48 healthy subjects(24 in fasting and 24 in fed trial)were randomized to receive a single oral dose of a 0.5 g pyrazinamide tablet(test or reference)per cycle.The plasma concentration of the drug was determined by liquid chromatography coupled to tandem mass spectrometry method.The pharmacokinetic parameters were calculated by WinNonlin v8.2,and the bioequivalence was evaluated by SAS 9.4.Results In the fasting group,the Cmax of the test and reference preparation of pyrazinamide tablets were(13.28±2.82)and(12.88±4.49)μg·mL-1,the AUC0-t were(139.17±26.58)and(138.63±28.92)h·μg·mL-1,the AUC0-∞ were(148.96±33.65)and(148.71±36.97)h·μg·mL-1 respectively.In the fed group,the Cmax of the test and reference preparation of pyrazinamide tablets were(11.89±1.96)and(11.99±1.92)μg·mL-1,the AUC0-t were(138.22±37.21)and(141.68±25.80)h·μg·mL-1,the AUC0-∞ were(152.20±32.41)and(151.04±28.05)h·μg·mL-,respectively.The 90％confidence intervals of Cmax,AUC0-t and AUC0-∞ geometric mean ratios of the test and reference preparation were all within 80.00％to 125.00％.The incidence of adverse events was 16.70％for both the test and reference preparation in the fasting group and 8.30％for both the test and reference preparation in the fed group,all of which were mild in severity.Conclusion The test and reference preparation of pyrazinamide tablets were bioequivalent,safe and well tolerated in healthy Chinese subjects under fasting and fed conditions.关键词
吡嗪酰胺片/药代动力学/生物等效性/液相色谱串联质谱法Key words
pyrazinamide tablet/pharmacokinetics/bioequivalence/liquid chromatography coupled to tandem mass spectrometry分类
医药卫生引用本文复制引用
叶丽冰,姚冲,陈莹蓉,童陆媛,杨涛,鲁潇,徐敏,金秋月,杨水新..吡嗪酰胺片在中国健康受试者中的生物等效性研究[J].中国临床药理学杂志,2024,40(15):2236-2240,5.基金项目
湖州市科技计划公益性应用研究基金资助项目(2021GZ71) （2021GZ71）
