Journal of Bioequivalence & Bioavailability

Ricardo Lima

Publications

• Research Article
  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, Teresa Nunes, Luis Almeida and Patrício Soares-da- SilvaRicardo Lima, Teófilo Vasconcelos, Rui Cerdeira, Marc Lefebvre, Eric Sicard, Teresa Nunes, Luis Almeida and Patrício Soares-da- Silva
  
  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.. View More»
  DOI: 10.4172/jbb.1000014

  Abstract PDF