Comparison of domestic and imported ceftibuten capsules in healthy volunteers

Objective:To compare the bioequivalence of domestic and imported ceftibuten capsules.Methods:A dose of 200 mg domestic or imported ceftibuten capsules was randomly given to 20 healthy volunteers in two-way cross-over design.Plasma concentrations of ceftibuten was determined by high performance liquid chromatography(HPLC) method.The pharmacokinetic parameters were calculated with the aid of DAS 2.0 pharmacokinetics software.The bioequivalence of the domestic and imported capsules were calculated by analysis of variance and two one side t-test.Results:The concentration-time curves of the two preparations were fitted to a two-compartment model.The main pharmacokinetic parameters of domestic or imported ceftibuten capsules were as follows:Tmax/h(2.660.37 vs 2.720.34);Cmax/mg/L(20.423.41 vs 19.933.29);AUC0-(104.8617.26) and(101.6817.44)mgh-1L-1;AUC0-t(103.3320.82) and(101.6817.44)mgh -1L-1,respectively.The relative bioavailability of domestic drug was(103.421.0)%.Conclusions:The domestic and imported capsules are bioequivalent.