Abstract
The study was to assess the bioequivalence of two cefuroxime axetil tablets. The test product was Cefxin tablet; the reference product was Zinnat tablet. Twelve healthy adult male volunteers participated in the study. Every subject received each formulation according to a completely double-blind randomized cross-over design with a one-week washout period before the second dose. Following oral administration of two cefuroxime axetil tablets, blood samples were drawn thirteen times over a period of ten hours. These samples were analyzed for cefuroxime concentrations using a sensitive and specific high performance liquid chromatography. Statistical assessments were performed, including ANOVA, power analysis and 90% confidence interval of ratio on various pharmacokinetic parameters derived from the plasma drug concentration-time profiles. The results indicated that the AUC(0-t), AUC(0- inf), peak concentration and mean resident time for the two products were not statistically significant different, i.e., the two products showed no difference in the rate and extent of drug absorption. Namely, there is no statistically significant difference between the bioavailability of Cefxin and Zinnat.
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