Comparative bioavailability of metronidazole tablets in healthy volunteers
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The pharmacokinetic parameters of standard and test preparations of metronidazole 250-mg tablets were measured in 12 healthy subjects following oral administration of a single 250-mg dose of each brand and compared for bioequivalence evaluation. Formulation factors were compared by performing assay, content uniformity and dissolution tests. A sensitive, rapid and precise high performance liquid chromatography (HPLC) method was used to measure concentrations of metronidazole in plasma samples collected up to 24 hours following each dose. Pharmacokinetic parameters, including peak plasma level (C max ), time to reach the peak plasma level (T max ), area under the time-concentration curve form time 0 to 24 hours and time 0 to infinity (AUC 0-24 , AUC 0-x , respectively), elimination rate constant (k el ) and half life (t1/2) were determined for both formulations. Analysis of data revealed that the variations in all pharmacokinetic parameters were not statistically significant (p > 0.05), and the blood concentration-time profile of both preparations were almost superimposable. Therefore, the test formulation was found to be bioequivalent with the standard innovator product, in terms of C max , AUC 0-24 and AUC 0-∞ .