Comparative bioavailability study of cefixime (equivalence to 100 mg/5 ml) suspension (Winex vs Suprax) in healthy male volunteers

Abstract

This investigation was carried out to evaluate the bioavailability of a new suspension formulation of cefixime (100 mg/5 ml), Winex, relative to the reference product, Suprax (100 mg/5 ml) suspension. The bioavailability study was carried out in 24 healthy male volunteers who received a single oral dose (200 mg) of the test (A) and the reference (B) products on 2 treatment days after an overnight fast of at least 10 hours. The treatment periods were separated by a one-week washout period. A randomized, balanced two-way crossover design was used. After dosing, serial blood samples were collected over a period of 16 hours. Plasma concentrations of cefixime were analyzed using a sensitive high-performance liquid chromatographic assay. The pharmacokinetic parameters for cefixime were determined using standard non-compartmental method. The parameters AUC0-t, AUC0-∞, Cmax, Kel, t1/2 and Cmax/AUC0-∞ were analyzed statistically using raw and log-transformed data. The time to maximum concentration (tmax) was analyzed using raw data. The parametric 90% confidence intervals of the mean values of the pharmacokinetic parameters: AUC0-t, AUC0-∞, Cmax, and Cmax/AUC0-∞ were within the range 80-125% which is acceptable for bioequivalence (using log-transformed data). The calculated 90% confidence intervals based on the ANOVA analysis for the mean test/reference ratios of AUC0-t, AUC0-∞, Cmax, and Cmax/AUC0-∞ were 88.93-107.10%, 89.09-107.11%, 89.63-108.58% and 96.85-105.29%, respectively. The test formulation was found bioequivalent to the reference formulation with regard to AUC0-t, AUC0-∞, and Cmax using the Schuirmann's two one-sided t-tests. Therefore, the two formulations were considered to be bioequivalent. © 2005 Dustri-Verlag Dr. K. Feistle.