Study of comparative bioavailability among two formulations containing hydroxyzine hydrochloride in healthy volunteers after a single dose administration

The study was performed to compare the bioavailability of two hydroxyzine hydrochloride 25 mg tablet formulation in 16 volunteers of both sexes. The study was conducted open with randomized two period crossover design and a two weeks wash out period. Plasma samples were obtained over a 96 h interv...

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Autores principales: Junior, Eduardo A., Duarte, Luciana F., Oliveira, Daniela A. de, Stein, Tatiane A.M., Nakamura, Marina M., Vanunci, Moisés L. P., Souza, Silvana F. de, Suenaga, Eunice M., Cruz, Alessandro de C.
Formato: Articulo
Lenguaje:Inglés
Publicado: 2011
Materias:
Farmacia
bioequivalence; hydroxyzine hydrochloride; LC-MS/MS; pharmacokinetics
Acceso en línea:http://sedici.unlp.edu.ar/handle/10915/8171
http://www.latamjpharm.org/resumenes/30/3/LAJOP_30_3_1_15.pdf
Aporte de:
SEDICI (UNLP) de Universidad Nacional de La Plata
id I19-R120-10915-8171
record_format dspace
institution Universidad Nacional de La Plata
institution_str I-19
repository_str R-120
collection SEDICI (UNLP)
language Inglés
topic Farmacia
bioequivalence; hydroxyzine hydrochloride; LC-MS/MS; pharmacokinetics
spellingShingle Farmacia
bioequivalence; hydroxyzine hydrochloride; LC-MS/MS; pharmacokinetics
Junior, Eduardo A.
Duarte, Luciana F.
Oliveira, Daniela A. de
Stein, Tatiane A.M.
Nakamura, Marina M.
Vanunci, Moisés L. P.
Souza, Silvana F. de
Suenaga, Eunice M.
Cruz, Alessandro de C.
Study of comparative bioavailability among two formulations containing hydroxyzine hydrochloride in healthy volunteers after a single dose administration
topic_facet Farmacia
bioequivalence; hydroxyzine hydrochloride; LC-MS/MS; pharmacokinetics
description The study was performed to compare the bioavailability of two hydroxyzine hydrochloride 25 mg tablet formulation in 16 volunteers of both sexes. The study was conducted open with randomized two period crossover design and a two weeks wash out period. Plasma samples were obtained over a 96 h interval. Hydroxyzine concentrations were analyzed by Liquid Chromatography with Tandem Mass Spectrometry (LC-MS/MS). Bioequivalence between the products was determined by calculating 90 % confidence intervals (90 % I.C) for the ratio of AUC<sub>0-t</sub> , AUC<sub>0-inf</sub> and C<sub>max</sub> values for the test and reference products, using logarithmic transformed data. The 90 % confidence intervals were 81.89-105.85 %, 84.61-105.30 %, and 84.04-108.66 %, respectively. Since the 90 % confidence intervals for C<sub>max</sub> , AUC<sub>0-t</sub> and AUC<sub>0-inf</sub> were within the 80-125 % interval proposed by the Food and Drug Administration, it was concluded that the two hydroxyzine hydrochloride formulations are bioequivalent in their rate and extent of absorption.
format Articulo
Articulo
author Junior, Eduardo A.
Duarte, Luciana F.
Oliveira, Daniela A. de
Stein, Tatiane A.M.
Nakamura, Marina M.
Vanunci, Moisés L. P.
Souza, Silvana F. de
Suenaga, Eunice M.
Cruz, Alessandro de C.
author_facet Junior, Eduardo A.
Duarte, Luciana F.
Oliveira, Daniela A. de
Stein, Tatiane A.M.
Nakamura, Marina M.
Vanunci, Moisés L. P.
Souza, Silvana F. de
Suenaga, Eunice M.
Cruz, Alessandro de C.
author_sort Junior, Eduardo A.
title Study of comparative bioavailability among two formulations containing hydroxyzine hydrochloride in healthy volunteers after a single dose administration
title_short Study of comparative bioavailability among two formulations containing hydroxyzine hydrochloride in healthy volunteers after a single dose administration
title_full Study of comparative bioavailability among two formulations containing hydroxyzine hydrochloride in healthy volunteers after a single dose administration
title_fullStr Study of comparative bioavailability among two formulations containing hydroxyzine hydrochloride in healthy volunteers after a single dose administration
title_full_unstemmed Study of comparative bioavailability among two formulations containing hydroxyzine hydrochloride in healthy volunteers after a single dose administration
title_sort study of comparative bioavailability among two formulations containing hydroxyzine hydrochloride in healthy volunteers after a single dose administration
publishDate 2011
url http://sedici.unlp.edu.ar/handle/10915/8171
http://www.latamjpharm.org/resumenes/30/3/LAJOP_30_3_1_15.pdf
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