中国临床药理学与治疗学2023，Vol.28Issue(12)：1365-1371,7.DOI:10.12092/j.issn.1009-2501.2023.12.006
醋酸地塞米松片在中国健康受试者中的生物等效性研究
Study on bioequivalence evaluation of dexamethasone acetate tab-lets in Chinese healthy volunteers
摘要
Abstract
AIM:To assess the bioequivalence of oral dexamethasone acetate tablets between the test and reference formulations in healthy adult Chinese subjects on an empty stomach and after meals.METHODS:A randomized,open,single-dose,two-cycle double crossover bioequivalence study was followed.Twenty-four healthy subjects were included in the fasting group,and 32 healthy subjects were included in the postprandial group,taking 2 tablets(0.75 mg/tablet)of the test formu-lation(T)or 3 tablets(0.50 mg/tablet)of the refer-ence formulation(R)per cycle for two cycles.The concentrations of dexamethasone acetate in hu-man plasma were determined using liquid chroma-tography-mass spectrometry,and the pharmacoki-netic parameters were calculated according to the non-atrial model using WinNonlin 8.0 software.The bioequivalence of both the test formulation and the reference formulation was evaluated.RESULTS:The pharmacokinetic parameters after oral adminis-tration of dexamethasone acetate tablets in a fast-ed state in subjects with the reference formulation are as follows:Tmax1.13(0.50,4.00)and 1.00(0.50,5.00)h,AUC0-t(72.25±21.55)and(69.23±17.76)ng· mL-1 h,Cmax(14.53±4.51)and(14.52±3.68)ng/mL,AUC0-∞(74.63±23.01)and(71.32±19.12)ng·mL-1·h.The pharmacokinetic parameters after oral admin-istration of dexamethasone acetate tablets in the postprandial state in subjects were as follows:Tmax 2.00(1.00,4.50)and 1.50(1.00,4.50)h,AUC0-t(81.57±21.28)and(76.06±13.63)ng·mL-1·h,Cmax(12.14±3.21)and(11.93±2.78)ng/mL,and AUC0-∞(85.12±23.92)and(78.95±14.99)ng·mL-1·h.The 90％confidence intervals for the geometric mean ratios of the main pharmacokinetic parameters of the test formulation of dexamethasone acetate to the reference formulation ranged from 80.00％to 125.00％under both fasting and postprandial condi-tions.CONCLUSION:Under fasting and postprandi-al conditions,the test formulation of dexametha-sone acetate tablets was bioequivalent to the refer-ence formulation of dexamethasone acetate tab-lets.关键词
醋酸地塞米松片/药代动力学/生物等效性Key words
dexamethasone acetate tablets/pharmacokinetics/bioequivalence分类
医药卫生引用本文复制引用
肖雷,徐媛媛,黄晓青,张文,曹阳,谢晶,周焕,黄顺旺..醋酸地塞米松片在中国健康受试者中的生物等效性研究[J].中国临床药理学与治疗学,2023,28(12):1365-1371,7.基金项目
安徽省自然科学基金(2008085QH401) （2008085QH401）
