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Bioequivalency of oral suspension formulations of cefixine
Author(s) -
Faulkner Robert D.,
Sia Louisa L.,
Barone Joseph S.,
Forbes St. J.,
Silber B. Michael
Publication year - 1989
Publication title -
biopharmaceutics and drug disposition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.419
H-Index - 58
eISSN - 1099-081X
pISSN - 0142-2782
DOI - 10.1002/bdd.2510100209
Subject(s) - bioequivalence , pharmacokinetics , crossover study , cefixime , oral administration , mathematics , medicine , chromatography , pharmacology , chemistry , placebo , antibiotics , biochemistry , alternative medicine , pathology , cephalosporin
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 ( C max ) 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 C max , the time to C max , 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 AUC 0→∞ 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.