Estudo de bioequivalencia de duas formulações comerciais de comprimidos de sertralina em voluntarios sadios

AUTOR(ES)
DATA DE PUBLICAÇÃO

1999

RESUMO

Objective: to compare the bioavailability of 2 sertraline tablets formulations (Tolrest@ from Laboratórios Biosintética, and Zoloft@ from Laboratórios Pfizer, Brazil) in 24 healthy volunteers of both sexes (12 male and 12 female) who received a single 50 mg dose of each sertraline formulation. Material and methods: the study was conducted open with randomized two-period crossover design and a 14-day washout period. Plasma samples were obtained over a 96-hour interval and sertraline concentrations were analyzed by combined reversed phase liquid chromatography and tandem mass spectrometry (LC-MS-MS) with positive ion electrospray ionization using selected ion monitoring method. From the plasma sertraline concentration vs. time curves the following pharmacokinetic parameters were obtained: AUC(O-96h), AUC(o-oo), Cmax, CmaxlAUC(O-96h), T max Ke, and t1/2. Results: pharmacokinetics parameters presented normal distribution according to Probit s plot and Kolmogorov Smirnov s test and the variance of AUC(O-96h), AUC(oao) or Cmax were homoscedastic. Geometric mean Tolrest@/Zoloft@ individual percent ratio was 95.22% for AUC(O-96h), 99.87% for Cmax, 100.4% for AUC(o-oo), 103.6% for Ke, 96.0% for t1/2 and 93.7% for T max. Conclusion: since the 90% CI for both Cmax and AUC(O-96h) mean ratio were within the 80-125% interval proposed by Food and Drug Administration, it was concluded that Tolrest@ was bioequivalent to Zoloft@ for both extent and rate of absortion in a single dose administration

ASSUNTO(S)

medicamentos - biodisponibilidade farmacologia farmacocinetica

ACESSO AO ARTIGO

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