Artículos de revistas
Gabapentin Bioequivalence Study: Quantification By Liquid Chromatography Coupled To Mass Spectrometry
Registro en:
Journal Of Bioequivalence And Bioavailability. , v. 3, n. 8, p. 187 - 190, 2011.
9750851
2-s2.0-80054041079
Autor
Abib Jr. E.
Duarte L.F.
Pereira R.
Pozzebon J.M.
Tosetti D.
Custodio J.M.C.
Institución
Resumen
The study was performed to compare the bioavailability of two gabapentin 400 mg capsule formulation (Gabapentin from Arrow Farmacêutica S/A as test formulation and Neurontin ® from Pfizer, Brazil, as reference formulation) in 26 volunteers of both sexes. The study was conducted open with randomized two period crossover design and a one week wash out period. Plasma samples were obtained over a 48 hour interval. The gabapentin was analyzed by LC/MS/MS, in the presence of pracetamole as internal standard. With plasma concentration vs. time curves, data obtained from this metabolite, the following pharmacokinetics parameters were obtained: AUC 0-t, AUC 0-inf and C max. Geometric mean of gabapentin/Neurontin ® 400 mg individual percent ratio was 100.58% AUC 0-t, 101.35% for AUC 0-inf and 97.76% for C max. The 90% confidence intervals were 92.00 - 109.95%, 93.00 - 110.44%, 88.41 - 108.10%, respectively. 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