Relative Bioavailability of Domestic Cefaclor Capsule in Healthy Volunteers

OBJECTIVE: The pharmacokinetics and relative bioavailability of domestic cefaclor capsule were studied in 12Chinese healthy volunteers. METHODS: Plasma cefaclor concentrations were measured using HPLC method. Each of all subjects was administered with a single oral dose of cefaclor capsule(500mg) in a randomized crossover study. RESULTS: Plasmaconcentration--time curves of domestic and imported cefaclor capsules fitted to a one--compartment open model with a first orderabsorption. The peak plasma levels(Cmax) averaged (16. 45 ± 3. 03) and (16. 72 ± 3. 83)μg/ml, times to reach the peak level(Tmax)were (0. 75 1±0. 21) and (0. 67 ± 0. 19)h, the elimination half lives(T1/2ke) were (0. 51 ± 0. 10) and (0. 50 ± 0. 12) h, the areas under the plasma concentration--time curve(AUC0-t) were (19. 58 ± 1. 85) and (19. 45 ± 2. 49) h/(μg' ml ) respectively. CONCLUSION: The results of statistical analysis showed that the two formulations were bioequivalent. The relative bioavailability ofdomestic capsule was (101. 39 ± 9. 73) %..