To compare the bioavailability of clarithromycin 500 mg tablets (Merck S.A Industrias Quinnicas, Sao Paulo, SP, Brazil, used as test formulation) and Klaricid(R) (Abbott Laboratorios do Brasil Ltda, Sao Paulo, SP, Brazil, used as reference formulation) in 24 healthy Volunteers. The study was...

To compare the bioavailability of clarithromycin 500 mg tablets (Merck S.A Industrias Quinnicas, Sao Paulo, SP, Brazil, used as test formulation) and Klaricid(R) (Abbott Laboratorios do Brasil Ltda, Sao Paulo, SP, Brazil, used as reference formulation) in 24 healthy Volunteers. The study was conducted using an open, randomized, two-period crossover design with one-week interval between doses. Blood samples were collected at pre-dose, 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours after the administration. 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 - 24 h), C-max and untransformed t(max). Intraindividual coefficient of variation (CV%) values were 14.25% and 12.62%, respectively for C-max and AUC(0 - 24 h), The geometric mean values (+/- SD) for AUC(0 - 24 h), (mu g x h/ml), AUC(0 - inf) (mu g x b/ml), and C-max (mu g/ml) for test medication were 18.56 (+/- 6.87), 18.8 (+/- 5.70) and 2.45 (+/- 0.88); the obtained values for reference medication were 18.29 (+/- 5.39), 19. 10 (+/- 7.21) and 2.5 (+/- 0.69). 90% CI for clarithromycin geometric mean of AUC(0 - 24 h), AUC(0 - inf) and C-max ratios (test/reference) were: 93.6-105.9%, 93.8-106.2% and 89-103.2%. The test medication was considered bioequivalent to the reference medication based on the rate and extent of absorption

CONSELHO NACIONAL DE DESENVOLVIMENTO CIENTÍFICO E TECNOLÓGICO - CNPQ

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