Bioequivalence of Cefdinir Dispersible Tablets in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:To study the pharmacokinetics and the bioequivalence of cefdinir dispersible tablets in healthy volunteers.METHODS:Microbiological assay method was used to determine the plasma concentration at different time in 20 healthy volunteers after oral administration of single dose of 400mg of cefdinir dispersible tablets(test preparation) and cefdinir capsule(reference preparation) by cross-over way.RESUTLS:The concentration-time curves of test preparation and reference preparation of cefdinir fitted one compartment open model.The pharmacokinetic parameters of the test preparation vs.the reference preparation were as follows:tmax(3.48?0.53)h vs.(3.60?0.48)h,Cmax(2.10?0.32)mg?L-1 vs.(2.15?0.26)mg?L-1.t1/2ke(2.41?0.39)h vs.(2.33?0.41)h,AUC0～12(9.51?1.65)mg?h?L-1 vs.(10.05?1.72)mg?h?L-1,AUC0～∞(10.43?1.62)mg?h?L-1 vs.(11.01?1.81)mg?h?L-1,respectively.The relative bioavailability of cefdinir dispersible tablet as against its reference preparation was(96.03?14.89)%.CONCLUSION:The two preparations of cefdinir were proved to be bioequivalent.