生物学的同等性とバイオアベイラビリティのジャーナル

概要

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

Eduardo Abib Jr, Luciana Fernandes Duarte and Renata Pereira

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 Farmac�utica Ltda*. Sifrol� (Pramipexole) from Boehringer Ingelheim do Brasil Qu�mica e Farmac�utica 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 Cmax and AUC0-t and 90% confidence intervals of correspondents were calculated to determine the bioequivalence. The means AUC0-t for test and reference formulation were 8201.90 pg.h/mL and 7891.56 pg.h/mL, for AUC0-∞ were 8574.71 pg.h/mL and 8288.01 pg.h/mL and, for Cmax 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% AUC0-t, 103.13% for AUC0-∞ and 100.81% for Cmax. The 90% confidence intervals were 98.02 � 109.51%, 97.95 � 108.59%, 93.06 � 109.21%, respectively. Since the 90% confidence intervals for Cmax, AUC0-t and AUC0-∞ 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.