Bioequivalency of oral suspension formulations of cefixine

✍ Scribed by Robert D. Faulkner; Louisa L. Sia; Joseph S. Barone; St. J. Forbes; Dr B. Michael Silber

• Publisher: John Wiley and Sons
• Year: 1989
• Tongue: English
• Weight: 379 KB
• Volume: 10
• Category: Article
• ISSN: 0142-2782
• DOI: 10.1002/bdd.2510100209

✦ Synopsis

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 3day washout period. Mean peak serum concentrations (C-) were 467,410, and 427pgml-' after the MS, RS, and SOL, respectively. Although comparison (ANOVA) of the mean pharmacokinetic parameters for cefixime found significant differences @ < 005) in C-, the time to C-, and area under the serum concentration time curve (AUC 0-a) 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 AUG,.. 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.