Pharmacokinetics and bioequivalence study of two formulations of Cefixime Suspension
Cefixime is a broad-spectrum oral antibiotic used for treating a wide variety of bacterial infections. This investigation was aimed to study the pharmacokinetics and bioequivalence of a new generic suspension containing 100 mg cefixime trihydrate per 5 ml as a test product against the reference formulation Suprax® suspension after administration to 28 Arabic healthy male adult subjects under fasting condition. Ten milliliters of each formulation (equivalent to 200 mg cefixime) were administered as a single dose applying a two-treatment, two-period, two-sequence, randomized crossover design with a one-week washout interval between dosing. Eighteen serial blood samples were collected from each subject before dosing and then up to 24.0 hours post-dosing. All the calculated pharmacokinetic parameters, including Cmax, AUC0–t, AUC0–∞, Tmax, Kelimination (lz), Thalf, and MRT were statistically analyzed by ANOVA tests. Ln-transformed values of the primary parameters used for bioequivalence evaluation, namely Cmax, AUC0–t, and AUC0–∞ were also statistically analyzed by ANOVA and 90% confidence interval tests. The ranges of 90% confidence interval tests for the Ln-transformed Cmax, AUC0–t, AUC0–∞ were 88.90-108.71, 89.71-109.30, and 89.83-109.23, respectively. Both products were well tolerated by all subjects. Based on FDA and EMEA criteria on bioequivalence, the results obtained from the present study exhibited bioequivalence between the test and the reference formulations of cefixime. Hence, the new generic suspension may be considered interchangeable with the reference product and prescribable in therapy with cefixime.
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