Bioavailability and pharmacokinetics of cefaclor

OBJECTIVE:

The bioavailability and pharmacokinetics of the domestic cefactor tablets was compared with those of cefaclor capsule made in USA.

METHOD:

A single oral dose of 500 mg cefaclor was given according to cross over design in 10 healthy volunteers. Plasma levels of cefaclor were measured by high-performance liquid chromatography method, The concentration-time curve of cefaclor was fitted to one compartment model measured by 3P87 program.

RESULTS:

The pharmacokinetic parameters of domestic and imported cefaclor were c(max) (9.87 ± 1.07) mg·L-1 and (10.44 ± 0.89) mg·L-1; t(max) (0.45 ± 0.04) h and (0.44 ± 0.07) h; t(1/2) (0.84 ± 0.07) h and (0.87 ± 0.11) h; AUC (16.69 ± 1.74) mg·h·L-1 and (18.02 ± 1.42) mg h·L-1, respectively. The relative bioavailability of domestic tablet was 92.62%.

CONCLUSION:

The results by two-one sided t-test showed that the two formulation of domestic and imported products were bioequivalent.