Pharmacokinetics and pharmacodynamics studies of azithromycin capsules in healthy Chinese subjects
10.13699/j.cnki.1001-6821.2024.01.020
- VernacularTitle:阿奇霉素胶囊在中国健康受试者中的生物等效性研究
- Author:
Peng-Fei XIE
1
;
Yuan-Lu CHEN
;
Han CHEN
;
Yan ZHOU
;
Peng YANG
;
Li-Zhong NIAN
;
Li-Ying ZUO
;
Yong-Dong ZHANG
Author Information
1. 郴州市第一人民医院Ⅰ期临床研究室,湖南郴州 423000;南华大学医院管理研究所,湖南郴州 423000
- Keywords:
azithromycin capsules;
pharmacokinetic;
bioequivalence;
safety
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(1):97-101
- CountryChina
- Language:Chinese
-
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.
