Comparative biodisponibility of a single dose captopril Formulations - doi:10.5020/18061230.2006.p5
Autor(a) principal: | |
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Data de Publicação: | 2012 |
Outros Autores: | , , , , |
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. |
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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 |