Evaluation of the Bioequivalence of Two Faropenem Formulations in Healthy Indian Subjects
19 December 2011 (online)
This paper presents the results of a two-period, two-treatment, crossover study conducted in 12 Indian male volunteers under fasting conditions to assess the bioequivalence of two oral formulations (Reference and Test) containing 200 mg of faropenem (CAS 106560–14–9). Both of the formulations were administered orally as a single dose separated by a washout period of 1 week. The content of faropenem in plasma was determined by a validated HPLC method with UV detection. The formulations were compared using the parameters area under the plasma concentration-time curve (AUC0–t), area under the plasma concentration-time curve from zero to infinity (AUC0–∞), peak plasma concentration (Cmax) and time to reach peak plasma concentration (tmax). The results indicated that there were no statistically significant differences between the logarithmically transformed AUC0–∞ and Cmax values between the test and reference formulation. The 90% confidence interval for the ratio of the logarithmically transformed AUC0–t AUC0–∞ and Cmax were within the bioequivalence limit of 0.8-1.25 and the relative bioavailability of the test formulation was 97.74% of that of the reference formulation.
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