Bioequivalence evaluation of 2 brands of cefuroxime axetil 250 mg tablets in healthy human volunteers.

摘要

OBJECTIVE: To assess the bioequivalence of 2 oral cefuroxime axetil (250 mg) tablets formulation. The reference preparation was Zinadol/Glaxo Wellcome, England, while the test preparation was cefuroxime axetil/Pharmathen, Athens, Greece. SUBJECTS, MATERIAL AND METHODS: The study was an open, randomized, 2-period, 2-sequence, 2-treatment crossover, involving 24 healthy male and female volunteers. All volunteers completed the study. Cefuroxime axetil plasma concentrations were measured utilizing a sensitive, reproducible and accurate HPLC method. Care was taken through the collection and analysis of the samples due to instability of cefuroxime axetil in light. Pharmacokinetic parameters used to assess bioequivalence were AUC(0-last), AUC(0-inf) for the extent of absorption and Cmax and tmax for the rate of absorption. Statistical evaluation of Cmax, AUC(0-last), and AUC(0-inf) was done using 2-way analysis of variance (ANOVA) after semilogarithmic transformation. Tmax values were tested using the distribution-free Hodges-Lehman interval. RESULTS: The parametric 90% confidence intervals for ratio T/R ranged from 98.91-111.65% (point estimate 105.09%) for AUC(0-last), 99.41-111.78% (point estimate 105.41%) for AUC(0-inf) and 87.61-102.89% (point estimate 94.95%) for Cmax, respectively. Based on the results of tmax, K(el) and t(1/2) there were no statistically significant differences. CONCLUSION: The 2 cefuroxime axetil preparations, examined in accordance with the European Union bioequivalence requirements, are equivalent with respect to rate and extent of absorption.