Bioequivalency of oral suspension formulations of cefixine

A study was performed in 24 healthy male subjects to establish that two suspension formulations of cefixime were bioequivalent to each other and to a reference oral solution. A single 400mg oral dose of the drug was given in a randomized three‐way crossover design as two suspensions (a research suspension (RS) used during clinical trials and a suspension intended for marketing (MS)) and a reference oral solution (SOL). Each dose was separated from the other by a 3‐day washout period. Mean peak serum concentrations (Cmax) were 4·67, 4·10, and 4·27 μg ml−1 after the MS, RS, and SOL, respectively. Although comparison (ANOVA) of the mean pharmacokinetic parameters for cefixime found significant differences (p < 0·05) in Cmax, the time to Cmax, and area under the serum concentration time curve (AUC 0∞) values among the three formulations, the mean differences were less than 20 per cent. No significant differences (p > 0·05) were found in either the elimination half‐life or renal clearance of unchanged drug. Overall, with a 98 per cent power to detect a 20 per cent difference in AUC0→∞ or urinary recovery values between the formulations tested, the results show that the MS was bioequivalent to the RS and that both suspensions were bioequivalent to the SOL.