Bioavailability and bioequivalence of erythromycin ethylsuccinate granules in healthy volunteers
- VernacularTitle:琥乙红霉素颗粒的人体生物利用度和生物等效性研究
- Author:
Gui-Xiong ZENG
;
Guo-Ping ZHONG
;
Xue-Ding WANG
;
Li-Hui HUANG
;
Min HUANG
;
- Publication Type:Journal Article
- Keywords:
Erythromycin ethylsuccinate;
Micrococcus luteus;
Bioavailability;
Bioequivalence
- From:
Chinese Journal of Infection and Chemotherapy
2006;0(04):-
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the bioavailability and bioequivalence of erythromycin ethylsuccinate granules in healthy male volunteers.Methods In a randomized two-period crossover study,20 healthy male volunteers received single 500 mg test and reference formulations of erythromyein ethylsuccinate granules.The plasma concentrations of erythromycin were assayed by microbiological method.Results The parameters of test and reference preparations were as follows:T_(max)(0.86?0.22)and (0.80?0.13)h,C_(max)(2.13?0.64)and(2.16?0.61)mg/L,t_(1/2)(2.04?0.2)and(1.97?0.4)h,AUC_(0-t)(4.96?1.73)and(4.63?1.52)mg?h/L,respectively.There was no significant difference between the two preparations.The rela- tive bioavailahility of the test granules was(109.1?22.8)%.Conclusions The two preparations of erythromycin ethylsucci- nate granules are bioequivalent.
