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 and Alessandro de Carvalho Cruz4
- *Corresponding Author:
- Dr. Eduardo Abib Junior
Scentryphar Clinical Research, 885
Barão de Itapura ave, Campinas
SP – Brazil- 13020-420
Tel: (19) 3232-6350
Fax: (19) 3231-6715
E-mail: [email protected]
Received Date: March 04, 2010; Accepted Date: April 02, 2010; Published Date: April 02, 2010
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
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.
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: AUC 0-t , AUC 0-inf and C max . Geometric mean of Clopidogrel/Plavix 75 mg individual percent ratio was 100.33% AUC 0-t , 98.96% for AUC 0-inf and 105.83% for C max . The 9 0% confidence intervals were 95.50–105.40%, 94 .45–103.69%, 95.91–116.78%, respectively. Since the 90% confidence intervals for C max , AUC 0-t and AUC 0-inf we r e within the 80–125% interval proposed by Food a nd 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.