Publication:

Open-label, randomized, crossover comparative bioavailability study of cefixime from two tablet formulations after single oral administration

Background Cefixime is an oral extended spectrum third generation cephalosporin, which has marked in vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms, effective in the treatment of community-acquired infections such as respiratory tract infection and urinary tract infection. The objective of this randomized, crossover study was to compare the bioequivalence (BE) of two tablets of test (Milixim® 200 mg, containing 200 mg of cefixime) with Reference formulation (Cefixime, 400 mg).

Methods A total of 12 healthy volunteers were randomly assigned to crossover, single-dose treatment regimens. Serial blood samples were collected, and plasma concentrations of cefixime were analyzed using the high-performance liquid chromatographic technique. Pharmacokinetic parameters and BE limits were calculated using non-compartmental methods.

Results The mean Cmax for the test and reference formulations were 4435.0298±149 and 4408.2150±1021 ng/mL, respectively. The mean area under the serum concentration curve (AUC)0-t were 38108.2614±8583.6535 and 38457.5791±8105.2529 ng/hr/mL The mean ratios (test: reference) for Cmax, AUC0-t, were 99.7% and 98.5%, respectively. There were no significant differences in pharmacokinetic parameters between groups. Overall, the 90% confidence interval for the intra-individual ratios of the log-transformed Cmax and AUC values of the two formulations were within the BE interval of 80-125%.

Conclusion The study has demonstrated the BE of milixim and reference formulation of cefixime.