Journal of Bioequivalence & Bioavailability

Bioequivalence Unit, Centro Avançado de Estudos e Pesquisas Ltd., Campinas, Brazil

Publications

• Research Article   
  Ketorolac Tromethamine Sublingual Tablet: A Randomized, Single-Dose, Two-Sequence, Two-Period, Crossover Study to Assess the Bioequivalence between Two Formulations
  Author(s): Jessica Meulman*, Marcelo Gomes Davanço, Fernando Costa, Fernando Bastos Canton Pacheco, Kadmiel Vinicio Santos Teixeira, Silvana Aparecida Calafatti Carandina and Celso Francisco Pimentel Vespasiano
  
  Ketorolac Tromethamine is a non-hormonal anti-inflammatory drug, with potent analgesic action, used to short- term treatment of moderate to severe acute pain. In order to register a generic product in Brazil, it was performed a bioequivalence study under fasting conditions between two ketorolac tromethamine sublingual tablets. The study was designed and conducted in accordance with ethical principles and current legislation, presenting an open, randomized, with two treatments, two periods and two sequences crossover design. For this study, 32 healthy men and women were selected; however, 30 participants completed the study. Blood samples were collected serially up to 24 h post-drug administration and plasma concentrations of ketorolac were obtained by a validated bioanalytical method, using ketorolac-d5 as an internal standard. A non-compartmental model was used t.. View more»
  

  DOI: 10.35248/0975-0851.22.14.484

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