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

Author(s): Ricardo Lima | Teófilo Vasconcelos | Rui Cerdeira | Marc Lefebvre | Eric Sicard, et al.

Journal: Journal of Bioequivalence & Bioavailability
ISSN 0975-0851

Volume: 01;
Issue: 03;
Start page: 093;
Date: 2009;
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Keywords: Eslicarbazepine acetate | Bioequivalence | Final tablet formulation | Research formulation

Purpose: To investigate the bioequivalence of the final tablet formulation of eslicarbazepine acetate (ESL) and the tablet formulation used in pivotal clinical studies.Methods: Single centre (Algorithme Pharma, Quebec, Canada) study consisting of three single-dose, randomized, two-way crossover sub-studies in healthy subjects. In each sub-study (n=20), the bioavailability of BIA 2- 005 (ESL active metabolite) following a given ESL tablet strength (400 mg, 600 mg or 800 mg) of the final formulation (Test) was compared with the corresponding tablet strength of the research formulation (Reference), under fasting conditions. The statistical method for testing bioequivalence was based upon the 90% confidence interval (90%CI) for the Test/Reference geometric mean ratio (GMR) for Cmax, AUC0-t and AUC0-&infi;. Bioequivalence was to be assumed when the 90%CI fell within the recommended acceptance interval 80.00%; 125.00%.Results: The Test/Reference GMR and 90%CI for BIA2-005 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 Cmax, AUC0-t and AUC0-&infi;, respectively; 600 mg tablets – 102.65% (97.27%; 108.33%), 102.40% (99.00%; 105.93%) and 102.38% (98.97%; 105.90%) for Cmax, AUC0-t and AUC0-&infi;, respectively; 800 mg tablets – 104.16% (95.44%; 113.67%), 100.34% (97.85%; 102.90%) and 99.88% (97.65%; 102.16%) for Cmax, AUC0-t and AUC0-&infi;, respectively.Conclusion: The 90%CI of all pharmacokinetic parametersof interest (Cmax, AUC0-t, and AUC0-&infi;) fell within the acceptance range of 80.00%; 125.00%. Therefore, bioequivalence of the final tablet formulation and the tablet formulation used in the pivotal clinical trials of ESL has been demonstrated.
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