Bioequivalency of Solid Oral Dosage Forms of Cefixime

A study was performed in 24 healthy subjects to determine whether tablet and capsule formulations of cefixime (CL 284,635; FK027), a new oral cephalosporin, given as a single 400 mg dose, were bioequivalent to one another and to a reference oral solution. Mean values of Cmax in serum were 3.87, 3.39, and 3.82 μg/ml after tablet, capsule and solution doses, respectively. Comparison (ANOVA) of the pharmacokinetic parameters showed significantly (P < 0.05) lower AUC0 → ∞ and Cmax values for the capsule than for the tablet; however, the mean differences were less than 16%. All pharmacokinetic parameters for the tablet, except for a significantly larger MRTni and tmax, were comparable to those for the solution. The bioavailability of cefixime based on AUC0 → ∞ and 24-h urinary recovery data from the tablet dosage form was slightly better (mean differences 14–16%) than from the capsule and virtually identical to that after the oral solution. The statistical power of the study was greater than 90% to detect a difference in AUC0 → ∞ values of 20%. Overall, based on AUC0 → ∞ comparisons, the results show that the tablet, capsule and oral reference solution are bioequivalent to one another.