Comparative Bioavailability: Two Pramipexole Formulations in Healthy Volunteers after a Single Dose Administration under Fasting Conditions

Le résumé fourni par la source

The study was performed to compare the bioavailability of two Pramipexole 0.125 mg tablet formulations: the test formulation was pramipezan ® (pramipexole) manufactured by Cobalt Pharmaceuticals, Canada/ Arrow Farmacêutica Ltda * .Sifrol ® (Pramipexole) from Boehringer Ingelheim do Brasil Química e Farmacêutica Ltda was used as reference formulation.The study was conducted open with randomized two period crossover design and 8 days wash out period in 48 volunteers of both sexes.Plasma samples were obtained over a 48 hour interval.Pramipexole was analyzed by LC-MS-MS in the presence of Tansulosina as internal standard.The mean ratio of parameters C max and AUC 0-t and 90% confidence intervals of correspondents were calculated to determine the bioequivalence.The means AUC 0-t for test and reference formulation were 8201.90 pg.h/mL and 7891.56 pg.h/mL, for AUC 0-∞ were 8574.71pg.h/mL and 8288.01 pg.h/mL and, for C max 642.09 pg/mL and 633.94 pg/mL, respectively.Geometric mean of pramipezan ® (pramipexole) /Sifrol ® 0.125 mg individual percent ratio was 103.61% AUC 0-t , 103.13% for AUC 0-∞ and 100.81% for C max .The 90% confidence intervals were 98.02 -109.51%,97.95 -108.59%,93.06 -109.21%,respectively.Since the 90% confidence intervals for C max , AUC 0-t and AUC 0-∞ were within the 80 -125% interval proposed by Food and Drug Administration, it was concluded that Pramipezan ® (pramipexole) 0.125 mg tablet was bioequivalent to Sifrol ® 0.125 mg tablet according to both the rate and extent of absorption.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.