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Renata Pereira
Renata Pereira
Brazil
Publications
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Research Article
Comparative Bioavailability: Two Pramipexole Formulations in Healthy Volunteers after a Single Dose Administration under Fasting Conditions
Author(s): Eduardo Abib Jr, Luciana Fernandes Duarte and Renata PereiraEduardo 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.. View More»
DOI: 10.4172/jbb.1000113