Journal of Bioequivalence & Bioavailability

Tatiane Antonelli Stein

Publications

• Research Article
  Comparative Biological Availability of Clopidogrel Formulation in Healthy Volunteers After a Single Dose Administration
  Author(s): Eduardo Abib Junior, Luciana Fernandes Duarte, Moisés Luís Pirasol Vanunci, Daniela Aparecida de Oliveira, Tatiane Antonelli Stein, Renata Pereira, Antonio Ricardo Amarante, Eunice Mayumi Suenaga and Alessandro de Carvalho CruzEduardo Abib Junior, Luciana Fernandes Duarte, Moisés Luís Pirasol Vanunci, Daniela Aparecida de Oliveira, Tatiane Antonelli Stein, Renata Pereira, Antonio Ricardo Amarante, Eunice Mayumi Suenaga and Alessandro de Carvalho Cruz
  
  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 .. View More»
  DOI: 10.4172/jbb.1000029

  Abstract PDF