Objective: To assess the bioavailability of a formulation of metformin\nhydrochloride 850 mg coated tablets as test, compared to a reference\nproduct with the same dosage form, in healthy volunteers of both\ngenders.\nMethod: This clinical trial was designed as randomised, comparative,\nsingle-dose, open-label, two-period, two-sequence, crossover study\nunder fasting conditions. 28 healthy volunteers (fourteen men and\nfourteen women) took part in the study. The 850 mg coated tablets\nformulations were administered in a single dose orally. Blood samples\nwere obtained prior to dosing and at 30 min, 1, 1:20; 1:40, 2,\n2:20, 2:40; 3, 3:20, 3:40 4, 4:30, 5, 6, 8, 12, 16, 24 and 36 hours\nafter drug administration with an one week washout period. Plasmatic\nconcentrations of metformin were measured by specific and validated\nanalytical methods based on high-performance liquid chromatography\ncoupled to mass spectrometry (HPLC/MS). The pharmacokinetics parameter\nAUC0-36h, AUC0-âË?ž and Cmax were tested for bioequivalence\nafter log transformation of data and ratios of Tmax were evaluated\nnon parametrically.\nFindings: Data from this study showed that the test and the reference\nformulation presented similar results, within the acceptance range\n(80-125%) for AUC0-âË?ž (area under curve) and Cmax (maximum serum\nconcentration of the drug) parameters, satisfying the bioequivalence\ncriteria of the Brazilian Health Surveillance Agency and FDA.\nConclusion: These results indicate that the two formulations of\nmetformin hydrochloride 850 mg coated tablets are bioequivalent,\nthus, it will be possible to ensure interchangeability between them,\nwhich can generate market competition and better access to this\ntreatment.
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