Comparative Bioavailability: Two Pramipexole Formulations in Healthy Volunteers after a Single Dose Administration under Fasting Conditions
- *Corresponding Author:
- Eduardo Abib Junior
Scentryphar Clinical Research
885, Barão de Itapura ave
Campinas, 13020-420, SP, Brazil
E-mail: [email protected]
Received Date: April 03, 2012; Accepted Date: May 26, 2012; Published Date: May 28, 2012
Citation: Abib E Jr, Duarte LF, Pereira R (2012) Comparative Bioavailability: Two Pramipexole Formulations in Healthy Volunteers after a Single Dose Administration under Fasting Conditions. J Bioequiv Availab 4: 056-059. doi: 10.4172/jbb.1000113
Copyright: © 2012 Abib E Jr, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
The study was performed to compare the bioavailability of two Pramipexole 0.125 mg tablet formulations: the test formulation was pramipezanÃ¯Â¿Â½ (pramipexole) manufactured by Cobalt Pharmaceuticals, Canada/ Arrow FarmacÃ¯Â¿Â½utica Ltda*. SifrolÃ¯Â¿Â½ (Pramipexole) from Boehringer Ingelheim do Brasil QuÃ¯Â¿Â½mica e FarmacÃ¯Â¿Â½utica 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 pramipezanÃ¯Â¿Â½ (pramipexole) /SifrolÃ¯Â¿Â½ 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 Ã¯Â¿Â½ 109.51%, 97.95 Ã¯Â¿Â½ 108.59%, 93.06 Ã¯Â¿Â½ 109.21%, respectively. Since the 90% confidence intervals for Cmax, AUC0-t and AUC0-∞ were within the 80 Ã¯Â¿Â½ 125% interval proposed by Food and Drug Administration, it was concluded that PramipezanÃ¯Â¿Â½ (pramipexole) 0.125 mg tablet was bioequivalent to SifrolÃ¯Â¿Â½ 0.125 mg tablet according to both the rate and extent of absorption.