Bioequivalência entre duas formulações de bromidrato de galantamina / Bioequivalence between two formulations of galantamine hydrobromide

Abstract

Objective: To comparatively evaluate the pharmacokinetic profile of galantamine hydrobromide present in the test drug (8 mg of galantamine hydrobromide in extendedrelease hard gelatinous capsule, Aché Laboratórios Farmaceuticos S.A.) and the reference drug (8 mg of galantamine hydrobromide in extended-release hard gelatinous capsule, Janssen Ortho LLC). Methods: Two bioequivalence studies were carried out, one in fasting state and the other post-prandial. Both studies were conducted in a cross-sectional, randomized, open-ended design with healthy research participants (n = 74 participants age: 18-50 years) after single dose administration of the test and reference drugs. To conclude the pharmacokinetic equivalence between the treatments, the ratio of the geometric means of the pharmacokinetic parameters should be between 80% and 125%, as well as the 90% confidence interval. Results: The mean values obtained for the pharmacokinetic parameters Cmax and ASC0-t, both for the fasting study and for the study conducted under standardized feeding, were within the range determined for the conclusion of bioequivalence (Cmax 106.65% -120.14% for the fasting study and 101.41% -112.40% for the post-prandial study and ASC0-t 91.96% -99.23% for the fasting study and 93.88% -101.31% for the feeding study). The power of the test was 100% in all cases and the confidence intervals are within the limits of acceptance of bioequivalence. Conclusions: Considering the results obtained, it was possible to observe that the drugs evaluated are bioequivalent both in fasting and in post-prandial condition and, therefore, interchangeable in medical practice.