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...
Guardado en:
| Autores principales: | , , , , , |
|---|---|
| Formato: | Articulo Comunicacion |
| Lenguaje: | Inglés |
| Publicado: |
2012
|
| Materias: | |
| 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: |
| Sumario: | 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. |
|---|