| Research Article |
Open Access |
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| Comparative Biological Availability of Clopidogrel Formulation in Healthy Volunteers After a Single Dose Administration |
| Eduardo Abib Junior1,2*, Luciana Fernandes Duarte2, Moisés Luís Pirasol Vanunci2,
Daniela Aparecida de Oliveira2, Tatiane Antonelli Stein2, Renata Pereira2,
Antonio Ricardo Amarante2, Eunice Mayumi Suenaga3, Alessandro de Carvalho Cruz4 |
| 1Department of Clinical Medicine, Faculty of Medical Sciences, State University of
Campinas (UNICAMP), 13083-970, Campinas, SP, Brazil |
| 2Scentryphar Clinical Research, 13020-420, Campinas, SP, Brazil |
| 3Nucleus of Bioequivalence and Clinical Research (NUBEC), 04041-152, São Paulo, SP, Brazil |
| 4Association for Development of the Medicine (SPDM), 04041-152, São Paulo, SP, Brazil |
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| *Corresponding author: |
Eduardo Abib Junior, Scentryphar Clinical
Research,
885, Barão de Itapura ave, Campinas,
SP – Brazil- 13020-42,
Tel: (19) 3232-6350,
Fax: (19) 3231-6715,
E-mail: eabib@scentryphar.com |
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| Received March 04, 2010; Accepted April 02, 2010; Published April 02,
2010 |
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| Citation: Abib E, Duarte LF, Vanunci MLP, Oliveira de DA, Antonelli S, et al.
(2010) Comparative Biological Availability of Clopidogrel Formulation in
Healthy Volunteers After a Single Dose Administration. J Bioequiv Availab 2:
045-049. doi: 10.4172/jbb.1000029 |
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| Copyright: © 2010 Abib E, et al. This is an open-access article distributed
under the terms of the Creative Commons Attribution License, which permits
unrestricted use, distribution, and reproduction in any medium, provided the
original author and source are credited. |
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| Abstract |
| The study was performed to compare the bioavailability
of two clopidogrel 75 mg tablet formulation (Clopidogrel
from Sandoz as test formulation and Plavix from Sanofi-
Synthelabo Ltda, Brazil, as reference formulation) in 42
volunteers of both sexes. The study was conducted open
with randomized two period crossover design and a one week
wash out period. Plasma samples were obtained over a 48
hour interval. The carboxylic acid of Clopidogrel, major
metabolite of Clopidogrel, was analyzed by LC-MS-MS,
in the presence of enalapril maleate as internal standard.
With plasma concentration vs. time curves, data obtained
from this metabolite, the following pharmacokinetics
parameters were obtained: AUC0-t, AUC0-inf and Cmax.
Geometric mean of Clopidogrel/Plavix 75 mg individual
percent ratio was 100.33% AUC0-t, 98.96% for AUC0-inf and
105.83% for Cmax. The 90% confidence intervals were
95.50–105.40%, 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% interval
proposed by Food and Drug Administration, it was
concluded that Clopidogrel 75 mg Tablet was bioequivalent
to Plavix 75 mg tablet according to both the rate and extent
of absorption. |
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