Gabapentin Bioequivalence Study: Quantification By Liquid Chromatography Coupled To Mass Spectrometry

dc.creatorAbib Jr. E.
dc.creatorDuarte L.F.
dc.creatorPereira R.
dc.creatorPozzebon J.M.
dc.creatorTosetti D.
dc.creatorCustodio J.M.C.
dc.date2011
dc.date2015-06-30T20:42:13Z
dc.date2015-11-26T14:53:54Z
dc.date2015-06-30T20:42:13Z
dc.date2015-11-26T14:53:54Z
dc.date.accessioned2018-03-28T22:05:45Z
dc.date.available2018-03-28T22:05:45Z
dc.identifier
dc.identifierJournal Of Bioequivalence And Bioavailability. , v. 3, n. 8, p. 187 - 190, 2011.
dc.identifier9750851
dc.identifier
dc.identifierhttp://www.scopus.com/inward/record.url?eid=2-s2.0-80054041079&partnerID=40&md5=2dad7da4b6830608d070b632f3449de2
dc.identifierhttp://www.repositorio.unicamp.br/handle/REPOSIP/108941
dc.identifierhttp://repositorio.unicamp.br/jspui/handle/REPOSIP/108941
dc.identifier2-s2.0-80054041079
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/1255030
dc.descriptionThe 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. Since the 90% confidence intervals for C max, AUC 0-t and AUC 0 -inf were within the 80 - 125% interval proposed by Food and Drug Administration, it was concluded that gabapentin 400 mg capsule was bioequivalent to Neurontin ® 400 mg capsule according to both the rate and extent of absorption. © 2011 Junior EA, et al.
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dc.description190
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dc.languageen
dc.publisher
dc.relationJournal of Bioequivalence and Bioavailability
dc.rightsaberto
dc.sourceScopus
dc.titleGabapentin Bioequivalence Study: Quantification By Liquid Chromatography Coupled To Mass Spectrometry
dc.typeArtículos de revistas


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