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|Type:||Artigo de periódico|
|Title:||Comparative Bioavailability: Two Pramipexole Formulations In Healthy Volunteers After A Single Dose Administration Under Fasting Conditions|
|Author:||Abib Jr. E.|
|Abstract:||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 8574.71 pg.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. © 2012 Abib E Jr, et al.|
|Appears in Collections:||Unicamp - Artigos e Outros Documentos|
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