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.455659Hughes, A.J., Daniel, S.E., Blankson, S., Lees, A.J., A clinicopathologic study of 100 cases of Parkinson's disease (1993) Arch Neurol, 50, pp. 140-148Eriksen, J.L., Wszolek, Z., Petrucelli, L., Molecular pathogenesis of Parkinson disease (2005) Arch Neurol, 62, pp. 353-357Samii, A., Nutt, J.G., Ransom, B.R., Parkinson's disease (2004) Lancet, 363, pp. 1783-1793Lesage, S., Brice, A., Parkinson's disease: From monogenic forms to genetic susceptibility factors (2009) Hum Mol Genet, 18, pp. 48-59Piercey, M.F., Pharmacology of pramipexole, a dopamine D3-preferring agonist useful in treating Parkinson's disease (1998) Clin Neuropharmacol, 21, pp. 141-151Gottwald, M.D., Bainbridge, J.L., Dowling, G.A., Aminoff, M.J., Alldredge, B.K., New pharmacotherapy for Parkinson's disease (1997) Ann Pharmacother, 31, pp. 1205-1217Lange, K.W., Clinical pharmacology of dopamine agonists in Parkinson's disease (1998) Drugs Aging, 13, pp. 381-389Lang, A.E., Lozano, A.M., Parkinson's disease. First of two parts (1998) N Engl J Med, 339, pp. 1044-1053Lang, A.E., Lozano, A.M., Parkinson's disease. Second of two parts (1998) N Engl J Med, 339, pp. 1130-1143Schapira, A.H.V., Science, medicine, and the future: Parkinson's disease (1999) BMJ, 318, pp. 311-314Grosset, K.A., Bone, I., Grosset, D.G., Suboptimal medication adherence in Parkinson's disease (2005) Mov Disord, 20, pp. 1502-1507Moller, J.C., Oertel, W.H., Pramipexole in the treatment of Parkinson's disease: New developments (2005) Expert Rev Neurother, 5, pp. 581-586Pinter, M.M., Pogarell, O., Oertel, W.H., Efficacy, safety, and tolerance of the non-ergoline dopamine agonist pramipexole in the treatment of advanced Parkinson's disease: A double blind, placebo controlled, randomised, multicentre study (1999) J Neurol Neurosurg Psychiatry, 66, pp. 436-441Shannon, K.M., Bennett Jr., J.P., Friedman, J.H., Efficacy of pramipexole, a novel dopamine agonist, as monotherapy in mild to moderate Parkinson's disease. The Pramipexole Study Group (1997) Neurology, 49, pp. 724-728Safety and efficacy of pramipexole in early Parkinson disease. A randomized dose-ranging study (1997) JAMA, 278, pp. 125-130. , AnonymousHubble, J.P., Koller, W.C., Cutler, N.R., Sramek, J.J., Friedman, J., Pramipexole in patients with early Parkinson's disease (1995) Clin Neuropharmacol, 18, pp. 338-347Hubble, J.P., Pre-clinical studies of pramipexole: Clinical relevance (2000) Eur J Neurol, 7, pp. 15-20Rascol, O., Brooks, D.J., Korczyn, A.D., de Deyn, P.P., Clarke, C.E., A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa (2000) N Engl J Med, 342, pp. 1484-1491Nilsson, D., Hansson, L.E., Johansson, K., Nystrom, C., Paalzow, L., Long-term intraduodenal infusion of a water based levodopa-carbidopa dispersion in very advanced Parkinson's disease (1998) Acta Neurol Scand, 97, pp. 175-183Stocchi, F., Vacca, L., Ruggieri, S., Olanow, C.W., Intermittent vs continuous levodopa administration in patients with advanced Parkinson disease: A clinical and pharmacokinetic study (2005) Arch Neurol, 62, pp. 905-910Debattista, C., Solvason, H.B., Breen, J.A., Schatzberg, A.F., Pramipexole augmentation of a selective serotonin reuptake inhibitor in the treatment of depression (2000) J Clin Psychopharmacol, 20, pp. 274-275