Journal of Bioequivalence & Bioavailability

Medical Department, Monte Verde S.A., Buenos Aires, Argentina

Publications

• Research Article   
  Levetiracetam Coated Tablet: A Randomized, Single-Dose, Two-Sequence, TwoPeriod, Crossover Study to Assess the Bioequivalence between Two Formulations
  Author(s): Marcelo Gomes Davanço*, Jessica Meulman, Fernando Costa, Leonardo de Souza Teixeira, Iram Moreira Mundim, Karini Bruno Bellorio, Carina Pimentel, Itapema Alves and Celso Francisco Pimentel Vespasiano
  
  Levetiracetam is an antiseizure medication prescribed to treat epilepsy. This study aimed to evaluate the bioequivalence between two formulations of levetiracetam coated tablets in order to meet regulatory requirements for marketing in Brazil. An open-label, randomized, single-dose, two-period, two-sequence, two-treatment crossover study was conducted in Brazilian healthy subjects of both genders. Subjects received a single dose of Levetiracetam 1000 mg test tablet (Zodiac Produtos Farmacêuticos S.A) and reference product (Etira®, Aché Laboratórios Farmacêuticos S.A.) under fasting conditions according to a randomly assigned order with a 7-day washout period. Serial blood samples were collected up to 36 h post-dose. Plasma concentrations of levetiracetam were obtained by a validated liquid chromatography-tandem mass spectro.. View more»
  

  DOI: 10.35248/0975-0851.22.14.458

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