alexa Bioequivalence of Final Tablet Formulation and Research
ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
Open Access

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Research Article

Bioequivalence of Final Tablet Formulation and Research Tablet Formulation of Eslicarbazepine Acetate in Healthy Volunteers

Ricardo Lima1, Teófilo Vasconcelos1, Rui Cerdeira1, Marc Lefebvre2, Eric Sicard2, Teresa Nunes1, Luis Almeida1, Patrício Soares-da-Silva1,*

1BIAL - Portela & Cª, SA, S. Mamede do Coronado, Portugal

2Algorithme Pharma Inc, Montreal, Québec, Canada

*Corresponding Author:
Dr. Professor Patricio Soares-da-Silva
Department of Research & Development, BIAL
À Av. da Siderurgia Nacional
4745- 457 S. Mamede do Coronado, Portugal
Phone : +351-229866100
Fax:+351- 229866192
E-mail : [email protected]

Received Date: July 30, 2009; Accepted Date: October 24, 2009; Published Date: October 24, 2009

Citation: Lima R, Vasconcelos T, Cerdeira R, Lefebvre M, Sicard E, et al. (2009) Bioequivalence of Final Tablet Formulation and Research Tablet Formulation of Eslicarbazepine Acetate in Healthy Volunteers. J Bioequiv Availab 1: 093-098. doi: 10.4172/jbb.1000014

Copyright: © 2009 Lima R, 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.

 

Abstract

Purpose: To investigate the bioequivalence of the final tablet formulation of eslicarbazepine acetate (ESL) and the tablet formulation used in pivotal clinical stu dies. Methods: Single centre (Algorithme Pharma, Quebec, Canada) study consisting of three single-dose, rand om- ized, two-way crossover sub-studies in healthy subj ects. In each sub-study (n=20), the bioavailability of BI A 2- 005 (ESL active metabolite) following a given ESL t ablet strength (400 mg, 600 mg or 800 mg) of the final fo rmula- tion (Test) was compared with the corresponding tab let strength of the research formulation (Reference), u nder fasting conditions. The statistical method for test ing bioequivalence was based upon the 90% confidence in ter- val (90%CI) for the Test/Reference geometric mean r atio (GMR) for C max , AUC 0-t and AUC 0- ∞ . Bioequivalence was to be assumed when the 90%CI fell within the recom- mended acceptance interval 80.00%; 125.00%. Results: The Test/Reference GMR and 90%CI for BIA 2-005 were as follows: 400 mg tablets – 105.37% (99 .57%; 111.52%), 102.83 (99.19%; 106.61%) and 102.83% (99.13%; 106.66%) for C max , AUC 0-t and AUC 0- ∞ , respec- tively; 600 mg tablets – 102.65% (97.27%; 108.33%), 102.40% (99.00%; 105.93%) and 102.38% (98.97%; 105.90%) for C max , AUC 0-t and AUC 0- ∞ , respectively; 800 mg tablets – 104.16% (95.44%; 113.67%), 100.34% (97.85%; 102.90%) and 99.88% (97.65%; 102.16%) for C max , AUC 0-t and AUC 0- ∞ , respectively. Conclusion: The 90%CI of all pharmacokinetic param- eters of interest (C max , AUC 0-t , and AUC 0- ∞ ) fell within the acceptance range of 80.00%; 125.00%. Therefore, bioequivalence of the final tablet formulation and the tab- let formulation used in the pivotal clinical trials of ESL has been demonstrated.

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