Bioequivalence test applied to a new lamivudine/zidovudine combined formulation tablet
A double-center, open-label, two-way crossover study was conducted in 24 healthy volunteers to assess the bioequivalence of a combined lamivudine/zidovudine tablet related to a reference and test drug products. The volunteers were randomly assigned to receive one lamivudine/zidovudine combination ta...
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Autores principales: | , , , , , |
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Formato: | Articulo |
Lenguaje: | Inglés |
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2009
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Acceso en línea: | http://sedici.unlp.edu.ar/handle/10915/7779 http://www.latamjpharm.org/trabajos/28/3/LAJOP_28_3_1_16_V0B1X2XE46.pdf |
Aporte de: |
id |
I19-R120-10915-7779 |
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record_format |
dspace |
institution |
Universidad Nacional de La Plata |
institution_str |
I-19 |
repository_str |
R-120 |
collection |
SEDICI (UNLP) |
language |
Inglés |
topic |
Farmacia Farmacología lamivudine; zidovudine; bioequivalencia Farmacocinética lamivudine; zidovudine; bioequivalence |
spellingShingle |
Farmacia Farmacología lamivudine; zidovudine; bioequivalencia Farmacocinética lamivudine; zidovudine; bioequivalence Souza, Jacqueline de Kano, Eunice K. Koono, Eunice E. Schramm, Simone G. Porta, Valentina Storpiritis, Sílvia Bioequivalence test applied to a new lamivudine/zidovudine combined formulation tablet |
topic_facet |
Farmacia Farmacología lamivudine; zidovudine; bioequivalencia Farmacocinética lamivudine; zidovudine; bioequivalence |
description |
A double-center, open-label, two-way crossover study was conducted in 24 healthy volunteers to assess the bioequivalence of a combined lamivudine/zidovudine tablet related to a reference and test drug products. The volunteers were randomly assigned to receive one lamivudine/zidovudine combination tablet of reference or test product with 7-days washout period between. Blood samples were collected up to 36 h post dose. Pharmacokinetic parameters were estimated. Drug products were bioequivalent if 90% confidence intervals for the ratio of least squares (CI 90%) means are under plasma concentration-time curve (AUC<sub>0-τ</sub> ) and absorption rate (C<sub>max</sub>) fell within 80 to 125% for log-transformed parameters. Test and reference products present data of AUC<sub>0-τ</sub> , C<sub>max</sub> referents to lamivudine and data of ASC∞ referents to zidovudine, in agreement of these limits. The result of C<sub>max</sub> (CI 90%) to zidovudine was: 116% (90- 141%), it has confirm that the zidovudine has high individual variability of absorption. |
format |
Articulo Articulo |
author |
Souza, Jacqueline de Kano, Eunice K. Koono, Eunice E. Schramm, Simone G. Porta, Valentina Storpiritis, Sílvia |
author_facet |
Souza, Jacqueline de Kano, Eunice K. Koono, Eunice E. Schramm, Simone G. Porta, Valentina Storpiritis, Sílvia |
author_sort |
Souza, Jacqueline de |
title |
Bioequivalence test applied to a new lamivudine/zidovudine combined formulation tablet |
title_short |
Bioequivalence test applied to a new lamivudine/zidovudine combined formulation tablet |
title_full |
Bioequivalence test applied to a new lamivudine/zidovudine combined formulation tablet |
title_fullStr |
Bioequivalence test applied to a new lamivudine/zidovudine combined formulation tablet |
title_full_unstemmed |
Bioequivalence test applied to a new lamivudine/zidovudine combined formulation tablet |
title_sort |
bioequivalence test applied to a new lamivudine/zidovudine combined formulation tablet |
publishDate |
2009 |
url |
http://sedici.unlp.edu.ar/handle/10915/7779 http://www.latamjpharm.org/trabajos/28/3/LAJOP_28_3_1_16_V0B1X2XE46.pdf |
work_keys_str_mv |
AT souzajacquelinede bioequivalencetestappliedtoanewlamivudinezidovudinecombinedformulationtablet AT kanoeunicek bioequivalencetestappliedtoanewlamivudinezidovudinecombinedformulationtablet AT koonoeunicee bioequivalencetestappliedtoanewlamivudinezidovudinecombinedformulationtablet AT schrammsimoneg bioequivalencetestappliedtoanewlamivudinezidovudinecombinedformulationtablet AT portavalentina bioequivalencetestappliedtoanewlamivudinezidovudinecombinedformulationtablet AT storpiritissilvia bioequivalencetestappliedtoanewlamivudinezidovudinecombinedformulationtablet |
bdutipo_str |
Repositorios |
_version_ |
1764820485090050048 |