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A bioequivalence study was performed on a new formulation of flecainide acetate in 100 mg tablets, using a formulation of the same drug already commercialized and in use and at the same dose. The study was conducted with a cross-over assay in 10 healthy volunteers at a single oral dose of 200 mg (two tablets). The parameters obtained according to the model employed, with both formulations studied, showed a considerable degree of between-subject variability. The parameters showing the highest between-subject variability were Ka (VC: 80.5 and 166.8%; tmax, VC: 40.8 and 48.0%, and Ke, VC: 39.4 and 35.1%) for formulations A and B, respectively, the parameter with the least variability being the MRT (VC 18.7 and 21.7%) for formulations A and B. Statistical analysis of the parameters characterizing the rate and extent to which the drug accesses to the systemic circulation, by application of statistical tests conventionally used in this kind of study- the "t" tests and ANOVA-revealed that there were no statistically significant differences among the parameters defining these processes for either formulation studied, thus permitting the assumption of bioequivalence between both formulations. The results obtained by application of the criteria of superposition and statistical moments show that there are no statistically significant differences with respect to the fraction of the dose of flecainide administered that reaches the systemic circulation after administration of the two tablet forms studied, both containing 100 mg of active principle (dose: 2 x 100 mg). |
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