中国临床药理学杂志2024，Vol.40Issue(1)：97-101,5.DOI:10.13699/j.cnki.1001-6821.2024.01.020
阿奇霉素胶囊在中国健康受试者中的生物等效性研究
Pharmacokinetics and pharmacodynamics studies of azithromycin capsules in healthy Chinese subjects
摘要
Abstract
Objective To evaluate the bioequivalence of the test preparation and reference preparation of azithromycin capsules in healthy Chinese subjects.Methods A total of 48 subjects were enrolled in this study using a randomized,open,two-sequence,cross design.Each subject received a single oral dose of azithromycin capsules test drug(T)or reference drug(R)for 250 mg.The concentrations of azithromycin in plasma were determined by Liquid Chromatograph Mass Spectrometer,and the pharmacokinetic parameters were calculated by WinNonlin 8.1 software to evaluate the bioequivalence.Results The main pharmacokinetic parameters of azithromycin after a single fasting dose of the test drug and the reference drug were as follows:the Cmax were respectively(319.89±127.35)and(330.41±122.11)ng·mL-1;AUC0-192h were respectively(2 423.04±587.15)and(2 489.97±685.73)ng·h·mL-1;AUC0-∞ were respectively(2 753.40±644.96)and(2 851.71±784.05)ng·h·mL-;tmax were respectively(2.60±1.11)and(2.62±1.13)h;t1/2 were respectively(76.76±15.14)and(79.83±17.14)h.The 90％confidence intervals for the geometric mean ratios of Cmax,AUC0-192h and AUC0-∞ of T and R were 87.52％-107.18％,91.46％-105.80％and 91.17％-105.06％,respectively.Conclusion The test preparation of azithromycin capsule was bioequivalent to the reference preparation under fasting condition.关键词
阿奇霉素胶囊/药代动力学/生物等效性/安全性Key words
azithromycin capsules/pharmacokinetic/bioequivalence/safety分类
医药卫生引用本文复制引用
谢朋飞,陈元璐,陈菡,周燕,杨鹏,年立忠,左莉英,张永东..阿奇霉素胶囊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(1):97-101,5.基金项目
郴州市科技发展计划基金资助项目(yfzx201912) （yfzx201912）
南华大学医院管理研究所基金资助项目(2020YJGL06) （2020YJGL06）
