Comparative biodisponibility of a single dose captopril Formulations - doi:10.5020/18061230.2006.p5

Detalhes bibliográficos
Autor(a) principal: Soares, Aline Kércia Alves
Data de Publicação: 2012
Outros Autores: Quental, Diana Pierre, Moraes, Maria Elisabete Amaral de, Moraes, Manoel Odorico de, Bezerra, Fernando Antônio Frota, Nucci, Gilberto de
Tipo de documento: Artigo
Idioma: por
Título da fonte: Revista Brasileira em Promoção da Saúde
Texto Completo: https://ojs.unifor.br/RBPS/article/view/953
Resumo: The aim of this study was to evaluate, on human volunteers, the performance of one captopril tablet formulation (Neo-Química Comércio Indústria Ltda) against one standard tablet formulation (Capoten® 50mg Bristol-Myers Squibb Brasil S.A).Twenty-four healthy volunteers, as assessed by clinical and laboratory test evaluations, were enrolled in the study. The study was of a two way randomised crossover design comparing both captopril formulations. Plasma samples for determination of captopril were obtained by pre-dose and at frequent intervals for up to 24h post to one of the single dose formulations and were quantified by a validated method employing high-pressure liquid chromatography coupled to mass spectrometry (LCMSMS). The subjects were monitored through-out the study and the formulations were considered to be well tolerated. The maximum reached concentration (Cmax) and areas under the curve (AUC0-24h) were compared. Captopril Cmax geometric mean ratio was 108.5% (90% IC=101.8-115.7) of Capoten® values. Captopril AUC(0-24h) geometric mean ratio was 109.3% (90% CI=102.7-116.3) of Capoten®. Since 90% CI for both Cmax and ratio AUC(0-24h) for captopril were within the 80 to 125% interval proposed by both the Food and Drug Administration (FDA) and the National Sanitary Surveillance Agency (ANVISA), it is concluded that Captopril Neo- Química was bioequivalent to Capoten® for both the rate and extent of absorption.
id UFOR-2_7b73b319f06e0a9488aafcffbe76a1c3
oai_identifier_str oai:ojs.ojs.unifor.br:article/953
network_acronym_str UFOR-2
network_name_str Revista Brasileira em Promoção da Saúde
repository_id_str
spelling Comparative biodisponibility of a single dose captopril Formulations - doi:10.5020/18061230.2006.p5Biodisponibilidade comparativa de doses únicas de formulações de captopril - doi:10.5020/18061230.2006.p5CaptoprilBioequivalênciaFarmacocinéticaCromatografia líquida de alta pressão.The aim of this study was to evaluate, on human volunteers, the performance of one captopril tablet formulation (Neo-Química Comércio Indústria Ltda) against one standard tablet formulation (Capoten® 50mg Bristol-Myers Squibb Brasil S.A).Twenty-four healthy volunteers, as assessed by clinical and laboratory test evaluations, were enrolled in the study. The study was of a two way randomised crossover design comparing both captopril formulations. Plasma samples for determination of captopril were obtained by pre-dose and at frequent intervals for up to 24h post to one of the single dose formulations and were quantified by a validated method employing high-pressure liquid chromatography coupled to mass spectrometry (LCMSMS). The subjects were monitored through-out the study and the formulations were considered to be well tolerated. The maximum reached concentration (Cmax) and areas under the curve (AUC0-24h) were compared. Captopril Cmax geometric mean ratio was 108.5% (90% IC=101.8-115.7) of Capoten® values. Captopril AUC(0-24h) geometric mean ratio was 109.3% (90% CI=102.7-116.3) of Capoten®. Since 90% CI for both Cmax and ratio AUC(0-24h) for captopril were within the 80 to 125% interval proposed by both the Food and Drug Administration (FDA) and the National Sanitary Surveillance Agency (ANVISA), it is concluded that Captopril Neo- Química was bioequivalent to Capoten® for both the rate and extent of absorption.O objetivo deste estudo foi avaliar, em voluntários sadios, a performance de uma formulação de um comprimido de Captopril (Neo-Química Comércio Indústria Ltda) comparando com a formulação de referência (Capoten® 50mg Bristol-Myers Squibb Brasil S.A). Vinte e quatro voluntários participaram do estudo após avaliações clínicas e laboratoriais. O estudo teve desenho aberto, randomizado e cruzado com dois períodos de internamento e intervalo de no mínimo duas semanas. Amostras plasmáticas para determinação de Captopril foram obtidas antes e em intervalos de até 24h após a administração de uma das formulações em dose única. Para a quantificação combinou-se cromatografia líquida de alta eficiência e espectrometria de massa. Os voluntários foram monitorados durante o estudo e as formulações consideradas bem toleradas. A concentração máxima obtida (Cmax) e a área sob a curva (AUC) foram comparadas. A média geométrica do Cmax para o Captopril Neo-Química foi 108,5 % (IC 90% = 101,8-115,7) e AUC0-24 foi 109,3% (90% IC=102,7-116,3) dos valores do Capoten®. Visto que 90% de Cmax, AUC0-24, apresentavam-se dentro do intervalo de confiança de 80-125% proposto pela Agência Nacional de Vigilância Sanitária (ANVISA) e pelo Food and Drug Administration (FDA), concluiu-se que o Captopril Neo-Química comprimido 50mg foi bioequivalente a Capoten??50mg, de acordo com sua taxa e extensão de absorção.Universidade de Fortaleza2012-01-04info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed Article""Avaliado pelos pares""Avaliado pelos pares"application/pdfhttps://ojs.unifor.br/RBPS/article/view/95310.5020/953Brazilian Journal in Health Promotion; Vol. 19 No. 1 (2006); 5-10Revista Brasileña en Promoción de la Salud; Vol. 19 Núm. 1 (2006); 5-10Revista Brasileira em Promoção da Saúde; v. 19 n. 1 (2006); 5-101806-1230reponame:Revista Brasileira em Promoção da Saúdeinstname:Universidade de Fortaleza (Unifor)instacron:UFORporhttps://ojs.unifor.br/RBPS/article/view/953/2116Soares, Aline Kércia AlvesQuental, Diana PierreMoraes, Maria Elisabete Amaral deMoraes, Manoel Odorico deBezerra, Fernando Antônio FrotaNucci, Gilberto deinfo:eu-repo/semantics/openAccess2012-01-10T12:18:00Zoai:ojs.ojs.unifor.br:article/953Revistahttps://periodicos.unifor.br/RBPS/oai1806-12301806-1222opendoar:2012-01-10T12:18Revista Brasileira em Promoção da Saúde - Universidade de Fortaleza (Unifor)false
dc.title.none.fl_str_mv Comparative biodisponibility of a single dose captopril Formulations - doi:10.5020/18061230.2006.p5
Biodisponibilidade comparativa de doses únicas de formulações de captopril - doi:10.5020/18061230.2006.p5
title Comparative biodisponibility of a single dose captopril Formulations - doi:10.5020/18061230.2006.p5
spellingShingle Comparative biodisponibility of a single dose captopril Formulations - doi:10.5020/18061230.2006.p5
Soares, Aline Kércia Alves
Captopril
Bioequivalência
Farmacocinética
Cromatografia líquida de alta pressão.
title_short Comparative biodisponibility of a single dose captopril Formulations - doi:10.5020/18061230.2006.p5
title_full Comparative biodisponibility of a single dose captopril Formulations - doi:10.5020/18061230.2006.p5
title_fullStr Comparative biodisponibility of a single dose captopril Formulations - doi:10.5020/18061230.2006.p5
title_full_unstemmed Comparative biodisponibility of a single dose captopril Formulations - doi:10.5020/18061230.2006.p5
title_sort Comparative biodisponibility of a single dose captopril Formulations - doi:10.5020/18061230.2006.p5
author Soares, Aline Kércia Alves
author_facet Soares, Aline Kércia Alves
Quental, Diana Pierre
Moraes, Maria Elisabete Amaral de
Moraes, Manoel Odorico de
Bezerra, Fernando Antônio Frota
Nucci, Gilberto de
author_role author
author2 Quental, Diana Pierre
Moraes, Maria Elisabete Amaral de
Moraes, Manoel Odorico de
Bezerra, Fernando Antônio Frota
Nucci, Gilberto de
author2_role author
author
author
author
author
dc.contributor.author.fl_str_mv Soares, Aline Kércia Alves
Quental, Diana Pierre
Moraes, Maria Elisabete Amaral de
Moraes, Manoel Odorico de
Bezerra, Fernando Antônio Frota
Nucci, Gilberto de
dc.subject.por.fl_str_mv Captopril
Bioequivalência
Farmacocinética
Cromatografia líquida de alta pressão.
topic Captopril
Bioequivalência
Farmacocinética
Cromatografia líquida de alta pressão.
description The aim of this study was to evaluate, on human volunteers, the performance of one captopril tablet formulation (Neo-Química Comércio Indústria Ltda) against one standard tablet formulation (Capoten® 50mg Bristol-Myers Squibb Brasil S.A).Twenty-four healthy volunteers, as assessed by clinical and laboratory test evaluations, were enrolled in the study. The study was of a two way randomised crossover design comparing both captopril formulations. Plasma samples for determination of captopril were obtained by pre-dose and at frequent intervals for up to 24h post to one of the single dose formulations and were quantified by a validated method employing high-pressure liquid chromatography coupled to mass spectrometry (LCMSMS). The subjects were monitored through-out the study and the formulations were considered to be well tolerated. The maximum reached concentration (Cmax) and areas under the curve (AUC0-24h) were compared. Captopril Cmax geometric mean ratio was 108.5% (90% IC=101.8-115.7) of Capoten® values. Captopril AUC(0-24h) geometric mean ratio was 109.3% (90% CI=102.7-116.3) of Capoten®. Since 90% CI for both Cmax and ratio AUC(0-24h) for captopril were within the 80 to 125% interval proposed by both the Food and Drug Administration (FDA) and the National Sanitary Surveillance Agency (ANVISA), it is concluded that Captopril Neo- Química was bioequivalent to Capoten® for both the rate and extent of absorption.
publishDate 2012
dc.date.none.fl_str_mv 2012-01-04
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
"Peer-reviewed Article"
"Avaliado pelos pares"
"Avaliado pelos pares"
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://ojs.unifor.br/RBPS/article/view/953
10.5020/953
url https://ojs.unifor.br/RBPS/article/view/953
identifier_str_mv 10.5020/953
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://ojs.unifor.br/RBPS/article/view/953/2116
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Universidade de Fortaleza
publisher.none.fl_str_mv Universidade de Fortaleza
dc.source.none.fl_str_mv Brazilian Journal in Health Promotion; Vol. 19 No. 1 (2006); 5-10
Revista Brasileña en Promoción de la Salud; Vol. 19 Núm. 1 (2006); 5-10
Revista Brasileira em Promoção da Saúde; v. 19 n. 1 (2006); 5-10
1806-1230
reponame:Revista Brasileira em Promoção da Saúde
instname:Universidade de Fortaleza (Unifor)
instacron:UFOR
instname_str Universidade de Fortaleza (Unifor)
instacron_str UFOR
institution UFOR
reponame_str Revista Brasileira em Promoção da Saúde
collection Revista Brasileira em Promoção da Saúde
repository.name.fl_str_mv Revista Brasileira em Promoção da Saúde - Universidade de Fortaleza (Unifor)
repository.mail.fl_str_mv
_version_ 1808844173424459776