Comparative bioavailability of two escitalopram formulations in healthy human volunteers

dc.creatorMendes, GD
dc.creatorBabadopulos, T
dc.creatorBau, FR
dc.creatorChen, LS
dc.creatorDe Nucci, G
dc.date2010
dc.dateAUG
dc.date2014-11-15T18:36:29Z
dc.date2015-11-26T17:21:28Z
dc.date2014-11-15T18:36:29Z
dc.date2015-11-26T17:21:28Z
dc.date.accessioned2018-03-29T00:08:58Z
dc.date.available2018-03-29T00:08:58Z
dc.identifierInternational Journal Of Clinical Pharmacology And Therapeutics. Dustri-verlag Dr Karl Feistle, v. 48, n. 8, n. 554, n. 562, 2010.
dc.identifier0946-1965
dc.identifierWOS:000281130800011
dc.identifierhttp://www.repositorio.unicamp.br/jspui/handle/REPOSIP/79125
dc.identifierhttp://www.repositorio.unicamp.br/handle/REPOSIP/79125
dc.identifierhttp://repositorio.unicamp.br/jspui/handle/REPOSIP/79125
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/1283373
dc.descriptionObjective: To assess the bio-equivalence of two escitalopram formulations (Test formulation: escitalopram (10 mg tablet) manufactured by Apsen Farmaceutica S.A.) Reference formulation: escitalopram (Lexapro(R); 10 mg tablet) from Lundbeck Brasil Ltda) in healthy volunteers of both sexes. Methods: The study was conducted using an open, randomized, two-period crossover design with at least a 21-day washout interval. Plasma samples were obtained over a 168 h period. Plasma escitalopram concentrations were analyzed by liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS) with positive ion electrospray ionization using multiple reaction monitoring (MRM). The following pharmacokinetic parameters were obtained from the escitalopram plasma concentration vs. time curves: AUC(last), AUC(inf) and C(max). Results: The limit of quantification for escitalopram was 0.2 ng.ml(-1). The geometric mean with corresponding 90% confidence interval (Cl) for Test/Reference percent ratios were 97.35% (90% Cl = 90.28 - 104.96%) for Cmax, 99.60% (90% Cl = 92.93 - 106.74%) for AUC(last) and 99.92% (90% Cl = 93.34 - 106.97%) for AUC(inf). Conclusion: Since the 90% CI for AUC(last), AUC(inf) and C(max), ratios were within the 80 - 125% interval proposed by the US FDA, it was concluded that escitalopram formulation manufactured by Apsen Farmaceutica S.A. is bioequivalent to the Lexapro(R) formulation in regard to both the rate and the extent of absorption.
dc.description48
dc.description8
dc.description554
dc.description562
dc.languageen
dc.publisherDustri-verlag Dr Karl Feistle
dc.publisherDeisenhofen-muenchen
dc.publisherAlemanha
dc.relationInternational Journal Of Clinical Pharmacology And Therapeutics
dc.relationInt. J. Clin. Pharmacol. Ther.
dc.rightsfechado
dc.sourceWeb of Science
dc.subjecttandem mass spectrometry
dc.subjectLC/MS/MS
dc.subjectbioavailability
dc.subjectpharmacokinetics
dc.subjectTandem Mass-spectrometry
dc.subjectAnxiety Disorders
dc.subjectQuantification
dc.subjectBioequivalence
dc.subjectPharmacokinetics
dc.subjectCitalopram
dc.subjectOxalate
dc.titleComparative bioavailability of two escitalopram formulations in healthy human volunteers
dc.typeArtículos de revistas


Este ítem pertenece a la siguiente institución