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| Titel: |
Comparative Biological Availability of Clopidogrel Formulation in Healthy Volunteers After a Single Dose Administration |
| Auteur: |
Eduardo Abib Junior Luciana Fernandes Duarte Moisés Luís Pirasol Vanunci Daniela Aparecida de Oliveira Tatiane Antonelli Stein |
| Verschenen in: |
Journal of bioequivalence & bioavailability |
| Paginering: | Jaargang 02 (2010) nr. 02 pagina's 045-049 |
| Jaar: |
2010 |
| Inhoud: |
The study was performed to compare the bioavailabilityof two clopidogrel 75 mg tablet formulation (Clopidogrelfrom Sandoz as test formulation and Plavix from Sanofi-Synthelabo Ltda, Brazil, as reference formulation) in 42volunteers of both sexes. The study was conducted openwith randomized two period crossover design and a one weekwash out period. Plasma samples were obtained over a 48hour interval. The carboxylic acid of Clopidogrel, majormetabolite of Clopidogrel, was analyzed by LC-MS-MS,in the presence of enalapril maleate as internal standard.With plasma concentration vs. time curves, data obtainedfrom this metabolite, the following pharmacokineticsparameters were obtained: AUC0-t, AUC0-inf and Cmax.Geometric mean of Clopidogrel/Plavix 75 mg individualpercent ratio was 100.33% AUC0-t, 98.96% for AUC0-inf and105.83% for Cmax. The 90% confidence intervals were95.50–105.40%, 94.45–103.69%, 95.91–116.78%,respectively. Since the 90% confidence intervals for Cmax,AUC0-t and AUC0-inf were within the 80–125% intervalproposed by Food and Drug Administration, it wasconcluded that Clopidogrel 75 mg Tablet was bioequivalentto Plavix 75 mg tablet according to both the rate and extentof absorption. |
| Uitgever: |
OMICS Publishing Group (provided by DOAJ) |
| Bronbestand: |
Elektronische Wetenschappelijke Tijdschriften |
Details van artikel 3 van 5 gevonden artikelen
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