Pharmacokinetics and Bioequivalence of 3 Kinds of Cefaclor Preparations in Healthy Volunteers

OBJECTIVE:To compare the pharmacokinetics of 3 kinds of cefaclor preparations in healthy volunteers,and to evaluate the bioequivalence of 3 kinds of preparations.METHODS:18 healthy volunteers received a single dose of 500 mg cefaclor dry suspension(test preparation 1),500 mg cefaclor dispersible tablets(test preparations 2)or 500 mg cefaclor tablets(reference prepration)respectively.The plasma concentrations of cefaclor were determined by HPLC.The pharmacokinetic parameters and relative bioequivalence of cefaclor were calculated using DAS software.RESULTS:The pharmacokinetic parameters of test preparation 1,test preparation 2 and reference preparation were as follows:cmax (13.94±3.76)μg·mL-1,(13.54±2.27)μg·mL-1 and(13.86±3.13)μg·mL-1;tmax(0.56±0.13)h,(0.55±0.14)h and(0.51±0.13)h;t1/2 (0.67±0.09)h,(0.68±0.15)h and(0.80±0.26)h;AUC0～4(15.16±2.58)μg·h·mL-1 ,(14.56±1.70)μg·h·mL-1and(14.74±2.07)μg·h·mL-1.F0～4 of test preparation 1 and test preparation 2 were(103.80±17.80)%and(100.50±18.40)%.There was no significant difference of cmax、tmax、AUC0～4、AUC0～∞ between 3 kinds of preparations.CONCLUSION:The dry suspension,dispersible tablets and reference tablets of cefaclor are bioequivalent.