Bioequivalencia de duas formulações de comprimidos de finasterida em voluntarios sadios

AUTOR(ES)
DATA DE PUBLICAÇÃO

2000

RESUMO

Two different finasteride tablet fonnulations were evaluated for their relative bioavailability (Flaxin@ tablets 5 mg, Merck S.A. Indústrias Químicas - Brazil as the test fonnulation vs Proscar@ tablets 5 mg, Merck Sharp &Dhõme, as the reference fonnulation) in 23 healthy male volunteers who received a single 5 mg oral dose of each preparation. The study was open, randomized with two-period crossover design and a 7-day washout period. Plasma samples were obtained over a 48-hour intervalo The finasteride concentrations were detennined by HPLC coupled to tandem mass spectrometry (LC-MS-MS). The ana1ytical method developed has a Limit of Quantitation (LOQ) of 0.50 nglml in plasma. The mean :t SD measured concentration was 2.05 :t 0.14 nglml (n=30) for the Quality Control of 2.00 nglmL (QCA), with precision of 6.9% and accuracy of 2.55%, while Quality Control of 20.00 nglmL , (QCC) the mean :t S.D. measured concentration was 20 :t 0.80 nglmL (n=30) with precision of 3.81% and accuracy of 0.09%. From the plasma finasteride concentration vs time curves the following I?harmacokinetics parameters were obtained: AUC(O-48), AUC(o¬00), Crnax, Crnax / AUC(O-48), ke, elimination half-life and tmax. Geometric mean F1axin@/Proscar@ individual percent ratio was 95.71 for AUC(O-48h) and 88.70% for Cmax. The 90% confidence interval for the geometric mean of the individual ratio test fonnulation/reference fonnulation was 95.70 - 120.20% for AUC(O-48h), 94.60 - 121.30 for AUC(o-oo) and 88.70 - 108 % for Crnax. Since, for both Cmax or AUC the 90% CI are within the interval proposed by the Food and Drug Admipistration test fonnulation is bioequivalent to reference fonnulation for both, the rate and extent of absorption after single dose administration

ASSUNTO(S)

comprimidos - medicina espectrometria de massa farmacocinetica formulas medicamentos

ACESSO AO ARTIGO

Documentos Relacionados