Bioequivalence Study of Two Formulations (Sachet and Tablet) of Cefixime after Single Oral Doses of 200mg in Healthy Male Volunteers

Abstract

The comparative bioavailability of two oral formulations of cefixime, the Oroken® 200mg tablet (reference formulation) and the novel Oroken® 200mg sachet (test formulation), was investigated in a single-dose crossover study in 18 healthy male volunteers. The data obtained in this study demonstrated bioequivalence of the two formulations. No statistical differences were observed for either maximum serum drug concentrations (Cmax) or areas under serum drug concentration versus time curves (AUC). 90% confidence intervals for mean Cmax and mean AUC (logarithmically transformed data) of the sachet as compared with the tablet were within the bioequivalence interval of 0.8 to 1.25. No differences between formulations in time to reach Cmax (tmax) or serum elimination half-life (t00BDβ) were evident. Moreover, after administration of either formulation, comparable amounts of unchanged cefixime were excreted in urine over similar time-frames. Clinical and biological tolerability was excellent for both formulations. The results of the present study show bioequivalence in terms of rate and extent of absorption of the tablet and sachet formulations of cefixime. The novel sachet formulation appears of considerable use for patients who are unable or unwilling to take tablets and for whom therapy with cefixime is recommended.