Pharmacokinetics and bioequivalence of cefprozil tablets in healthy volunteers
10.3969/j.issn.1001-6821.2010.01.007
- VernacularTitle:头孢丙烯片在健康人体的药代动力学和生物等效性
- Author:
Li-Zi ZHAO
1
;
Guo-Ping ZHONG
;
Xin-Ping XUE
;
Zhi-Min OU
;
Gui-Xiong ZENG
;
Li-Hui HUANG
;
Zhong-Fu MA
;
Xiao CHEN
;
Min HUANG
Author Information
1. 中山大学
- Keywords:
cefprozil;
HPLC;
pharmacokinetics;
bioequivalence
- From:
The Chinese Journal of Clinical Pharmacology
2010;26(1):23-27
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the pharmacokineties and bioequiva-lenee of two demostic cefprozil tablets.Methods Twenty healthy volun-teers were randomized into two groups,whose plasma concentrations of cis and trans isomers of eefprozil were determined at different time after single oral dose of 1 g cefprozil tablets by own control by HPLC method.The pharmacokinetic pammeters were computed and which were experi-enced variance analysis.Results Gis cefprozil:the main pharmaeoki-netic parameters of refe:rence and trial cefprozil tablets were as follows:t_(max) were(2.4±1.0),(2.3±0.8)h;C_(max) were(15.4±3.5),(14.8±2.8)μg·mL~(-1);t_(1/2) were(1.4±0.1),(1.4±0.1)h;MRT were (3.4±0.6),(3.4±0.6)h;AUC_(0-t) were(61.2±10.6),(60.3±11.4)μg·h·mL~(-1);AUC_(0-∞) were(64.7±11.2),(64.5±11.7)μg·h·mL~(-1),respectively.Trans cefprozil:the relative bioavailability of the trial preparation was(99.3±14.5)%.Trans cefprozil:the main pharmacokinetic parameters of reference and trial cefprozil tablets were as follows:t_(max) were(2.4±0.9),(2.4±0.9)h;C_(max) were(1.6±0.3),(1.5±0.3)μg·mL~(-1);t_(1/2) were(1.2±0.2),(1.5±0.6)h;MRT were(3.2±0.7),(3.2±0.7)h;AUC_(0-t) were(6.1±1.4),(5.6±1.3)μg·h·mL~(-1);AUC_(0-∞) were(6.1±1.4),(5.6±1.3)μg·h·mL~(-1),respectively.The relative bioavailability of the trial preparation was(94.0±17.5)%.Conclusion The results shows that the trial preparation and the reference prepara-tion of cefprozil were bioequivalent.
