Bioequivalence Study of Deferiprone In Healthy Pakistani Volunteers

The study was conducted to evaluate the bioequivalence of deferiprone 500 mg with innovator drug in Pakistani men. Twenty four healthy volunteers were enrolled in this study. Each volunteer take two tablets of generic and innovator deferiprone with two-week washout period. Blood samples were colle...

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Detalles Bibliográficos
Autores principales: Abbas, Mateen, Khan, Abdul M., Waheed, Naila, Riffat, Sualeha, Ashraf, Muhammad, Amin, Sadia
Formato: Articulo Comunicacion
Lenguaje:Inglés
Publicado: 2012
Materias:
Farmacia
Farmacología
bioequivalence; pharmacokinetics; deferiprone; pakistani men
Farmacocinética
Acceso en línea:http://sedici.unlp.edu.ar/handle/10915/18151
http://www.latamjpharm.org/resumenes/31/2/LAJOP_31_2_2_9.pdf
Aporte de:
SEDICI (UNLP) de Universidad Nacional de La Plata
id I19-R120-10915-18151
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
bioequivalence; pharmacokinetics; deferiprone; pakistani men
Farmacocinética
spellingShingle Farmacia
Farmacología
bioequivalence; pharmacokinetics; deferiprone; pakistani men
Farmacocinética
Abbas, Mateen
Khan, Abdul M.
Waheed, Naila
Riffat, Sualeha
Ashraf, Muhammad
Amin, Sadia
Bioequivalence Study of Deferiprone In Healthy Pakistani Volunteers
topic_facet Farmacia
Farmacología
bioequivalence; pharmacokinetics; deferiprone; pakistani men
Farmacocinética
description The study was conducted to evaluate the bioequivalence of deferiprone 500 mg with innovator drug in Pakistani men. Twenty four healthy volunteers were enrolled in this study. Each volunteer take two tablets of generic and innovator deferiprone with two-week washout period. Blood samples were collected at predetermined time intervals. Plasma deferiprone levels were analyzed using validated HPLC method. Pharmacokinetic parameters computed non-compartmentally after logarithmic transformation of data. The mean relative bioavailability was 104 %. The mean Cmax , AUC0–t , AUC0–∞ for generic drug were 14.41, 40.49, and 42.84 μg.h/mL and for innovator were 12.68, 38.63, and 40.75 μg.h/mL, respectively. Mean ratio (generic/innovator) of AUC0–t at 90 % CI was 0.9737-1.1150 and for Cmax was 0.99876- 1.2425. Hence, the mean ratio of 90 % confidence interval of AUC0–t and Cmax lie within the acceptable limit of (0.80-1.25) for bioequivalence. Therefore, it was concluded that Ferinil and Ferriprox was proved to be bioequivalent in healthy Pakistani men.
format Articulo
Comunicacion
author Abbas, Mateen
Khan, Abdul M.
Waheed, Naila
Riffat, Sualeha
Ashraf, Muhammad
Amin, Sadia
author_facet Abbas, Mateen
Khan, Abdul M.
Waheed, Naila
Riffat, Sualeha
Ashraf, Muhammad
Amin, Sadia
author_sort Abbas, Mateen
title Bioequivalence Study of Deferiprone In Healthy Pakistani Volunteers
title_short Bioequivalence Study of Deferiprone In Healthy Pakistani Volunteers
title_full Bioequivalence Study of Deferiprone In Healthy Pakistani Volunteers
title_fullStr Bioequivalence Study of Deferiprone In Healthy Pakistani Volunteers
title_full_unstemmed Bioequivalence Study of Deferiprone In Healthy Pakistani Volunteers
title_sort bioequivalence study of deferiprone in healthy pakistani volunteers
publishDate 2012
url http://sedici.unlp.edu.ar/handle/10915/18151
http://www.latamjpharm.org/resumenes/31/2/LAJOP_31_2_2_9.pdf
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AT riffatsualeha bioequivalencestudyofdeferiproneinhealthypakistanivolunteers
AT ashrafmuhammad bioequivalencestudyofdeferiproneinhealthypakistanivolunteers
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bdutipo_str Repositorios
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