To compare the bioavailability of amoxicillin 875 mg tablets (EMS Sigma Pharma used as test formulation) and AmoxilO BD 875 mg tablets (GlaxoSmithKline used as reference formulation) in 26 healthy volunteers. 26 healthy volunteers (13 males and 13 females) received each formulation in an open, 2 x 2...

To compare the bioavailability of amoxicillin 875 mg tablets (EMS Sigma Pharma used as test formulation) and AmoxilO BD 875 mg tablets (GlaxoSmithKline used as reference formulation) in 26 healthy volunteers. 26 healthy volunteers (13 males and 13 females) received each formulation in an open, 2 x 2 crossover, randomized study with seven days of washout period between doses. Plasma samples were obtained over a 12-hour interval after administration. Plasmatic amoxicillin concentrations were obtained by combined reversed-phase liquid chromatography and mass spectrometry with positive ion electrospray ionization using the select ion monitoring method. AUC was calculated by the trapezoidal rule extrapolation method. C-max and t(max) were compiled from the plasmatic concentration-time data. Analysis of variance was carried out using logarithmically transformed AUC(0-inf), AUC(0-12 h), C-max and untransformed t(max). Results: The mean values (+/- SD) for AUC(0-12) (h), (mu g x h x ml(-1)), AUC(0 - 12 h) (mu g x h x ml(-1)), C-max (mu g x ml(-1)), t(1/2) (h) and t(max) (h), were, respectively: 55.42 (+/- 16.85), 55.42 (+/- 16.85), 18.59 (+/- 6.3), 1.49 (+/- 1.57) and 2.04 (+/- 0.75) concerning the test formulation, and 51.11 (+/- 18.9), 51.29 (+/- 19.12), 17.83 (+/- 5.86), 1.52 (+/- 1.31) and 2.02 (+/- 0.87) concerning the reference formulation. Confidence intervals (90%) of amoxicillin means of AUC(0 - 12 h), and C-max ratios (test/reference) were: 0.961 - 1.149 and 0.914 - 1.142 respectively, agreeing with the bioequivalence criteria established by the Brazilian National Health Surveillance Agency. Both formulations were bioequivalent based on both the rate and extent of absorption

COORDENAÇÃO DE APERFEIÇOAMENTO DE PESSOAL DE NÍVEL SUPERIOR - CAPES

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