Pharmacokinetics and bioequivalence of cefaclor for suspension after single dose administration in healthy volunteers

AIM To study the pharmacokinetics and bioequivalence of two cefaclor for suspensions. METHODS A single oral administration of 250 mg test and reference of cefaclor for suspensions were given to 20 healthy male volunteers according to a randomized crossover design. The concentrations of cefaclor in plasma were determined by a HPLC-MS / MS method. The pharmacokinetic parameters were calculated and the bioequivalence were compared by DAS (Ver 1.0) program. RESULTS The pharmacokinetics parameters of test and reference preparations were as follows: ρmax were (9.0 ± s 1.7) and (9.6 ± 1.6) mg·L-1, tmax were (0.37 ± 0.12) and (0.35 ± 0.05) h, t1/2 were (0.88 ± 0.16) and (0.87 ± 0.11) h, AUC0-5 h were (7.9 ± 1.0) and (7.9 ± 1.1) mg·h·L-1, AUC0-∞ were (8.0 ± 1.0) and (8.0 ± 1.1) mg·h·L-1, respectively. There were no significant differences in tmax, ρmax, AUC0-5 h, AUC0-∞, and t1/2 between the two preparations (P 0.05). The relative bioavailability of test suspensions was (101 ± 12)%. CONCLUSION The test and reference prepara- tions were bioequivalence.