Research Article
Bioequivalence Study of Two Oral Formulations of Memantine Tablets in Healthy Brazilian Volunteers after a Single Dose Administration
Author(s): Isabela Costa César, Ricardo Martins Duarte Byrro, Fabiana Fernandes de Santana e Silva, Leonardo de Souza Teixeira, Fernanda Crunivel de Abreu and Gerson Antônio PianettiIsabela Costa César, Ricardo Martins Duarte Byrro, Fabiana Fernandes de Santana e Silva, Leonardo de Souza Teixeira, Fernanda Crunivel de Abreu and Gerson Antônio Pianetti
The bioequivalence of a single dose of memantine (Clomenac®) 10 mg tablets manufactured by Cobalt Pharmaceuticals, Canada/Arrow Farmacêutica Ltda was compared with a reference memantine 10 mg tablets (Ebix®, Lundbeck Inc). The single-dose, randomized-sequence, open-label, two period crossover study was conducted on a total of 26 Brazilian healthy volunteers of both genders. Nineteen blood samples were taken during 72 h. Samples were frozen and kept until time of analysis. Plasma concentrations of memantine were determined using a validated UPLC-MS/MS method. Confidence intervals (CI, 90%) for the peak plasma concentration (Cmax) and area under the concentration-time curve (AUC0-t) were determined by calculating log-transformed data. T.. View More»
DOI:
10.4172/jbb.1000104