Comparative bioavailability of two digoxin formulations: determination in human plasma by microparticle enzyme immunoassay
The present study was performed to compare the bioavailability of two digoxin 0.25 mg tablet formulation in 30 volunteers of both sexes. The study was conducted open with randomized two period crossover design and a three-week washout period. Plasma samples were obtained over a 144 h interval. Digox...
Guardado en:
| Autores principales: | , , , , , , |
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| Formato: | Articulo Comunicacion |
| Lenguaje: | Inglés |
| Publicado: |
2011
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| Materias: | |
| Acceso en línea: | http://sedici.unlp.edu.ar/handle/10915/8288 http://www.latamjpharm.org/resumenes/30/6/LAJOP_30_6_2_7.pdf |
| Aporte de: |
| id |
I19-R120-10915-8288 |
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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 bioequivalence; digoxin; pharmacokinetics; volunteers Farmacocinética Glicósidos Cardíacos Inmunoensayo |
| spellingShingle |
Farmacia bioequivalence; digoxin; pharmacokinetics; volunteers Farmacocinética Glicósidos Cardíacos Inmunoensayo Junior, Eduardo A. Duarte, Luciana F. Vanunci, Moisés L. P. Silva, Lara C. Pereira, Renata Calafatti, Silvana Junior, José P. Comparative bioavailability of two digoxin formulations: determination in human plasma by microparticle enzyme immunoassay |
| topic_facet |
Farmacia bioequivalence; digoxin; pharmacokinetics; volunteers Farmacocinética Glicósidos Cardíacos Inmunoensayo |
| description |
The present study was performed to compare the bioavailability of two digoxin 0.25 mg tablet formulation in 30 volunteers of both sexes. The study was conducted open with randomized two period crossover design and a three-week washout period. Plasma samples were obtained over a 144 h interval. Digoxin concentrations were analyzed by a validated microparticle enzyme immunoassay with optical detection by fluorescence. Bioequivalence between the products was determined by calculating 90 % confidence intervals (90 % I.C) for the ratio of AUC<sub>0-72h</sub> and C<sub>max</sub> values for the test and reference products, using logarithmic transformed data. The 90 % confidence intervals were 86.98-118.33 %, and 84.52–98.76 %, respectively. Since the 90 % confidence intervals for C<sub>max</sub> and AUC<sub>0-72h</sub> were within the 80-125 % interval proposed by Food and Drug Administration, it was concluded that the two Digoxin formulations are bioequivalent in their rate and extent of absorption. |
| format |
Articulo Comunicacion |
| author |
Junior, Eduardo A. Duarte, Luciana F. Vanunci, Moisés L. P. Silva, Lara C. Pereira, Renata Calafatti, Silvana Junior, José P. |
| author_facet |
Junior, Eduardo A. Duarte, Luciana F. Vanunci, Moisés L. P. Silva, Lara C. Pereira, Renata Calafatti, Silvana Junior, José P. |
| author_sort |
Junior, Eduardo A. |
| title |
Comparative bioavailability of two digoxin formulations: determination in human plasma by microparticle
enzyme immunoassay |
| title_short |
Comparative bioavailability of two digoxin formulations: determination in human plasma by microparticle
enzyme immunoassay |
| title_full |
Comparative bioavailability of two digoxin formulations: determination in human plasma by microparticle
enzyme immunoassay |
| title_fullStr |
Comparative bioavailability of two digoxin formulations: determination in human plasma by microparticle
enzyme immunoassay |
| title_full_unstemmed |
Comparative bioavailability of two digoxin formulations: determination in human plasma by microparticle
enzyme immunoassay |
| title_sort |
comparative bioavailability of two digoxin formulations: determination in human plasma by microparticle
enzyme immunoassay |
| publishDate |
2011 |
| url |
http://sedici.unlp.edu.ar/handle/10915/8288 http://www.latamjpharm.org/resumenes/30/6/LAJOP_30_6_2_7.pdf |
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Repositorios |
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1764820488723365888 |