Bioequivalence evaluation of two oral formulations of Dexketoprofen-trometamol (solution and tablets) in healthy subjects: Results from a randomized, single-blind, crossover study

Abstract

This single-center, single-blind, randomized, 2-period, 2-treatment, crossover, single-dose-per-period, 2-sequence study evaluated the bioequivalence of a test dexketoprofen-trometamol (oral solution) compared with a reference 25 mg dexketoprofen-trometamol in 27 healthy adults under fasting conditions. Blood samples were collected pre-dose and at specified intervals across an 8-hour period following administration and were analyzed for dexketoprofen-trometamol using a validated reverse-phase high-performance liquid chromatography method. Drug products were considered to be bioequivalent if confidence intervals of natural log-transformed Cmax, AUC0-t, and AUC0-∞ data were within the range of 80-125%. Results showed an earlier Cmax which might traduce in faster onset of action for solution formulation. However, criteria for bioequivalence were met for AUC0-t, and AUC0-∞. All measured dexketoprofen-trometamol concentrations in this study were within a safe therapeutic range, and no adverse events were reported. *Correspondence to: Jorge González Canudas, Av. Paseo de las Palmas, #340, Third Floor, Col. Lomas de Chapultepec, Alcaldía Miguel Hidalgo, C.P. 11000, Mexico, Tel: 5254883761; E-mail: jogonzalez@silanes.com.mx