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 C max , AUC 0-t , and AUC 0-∞ data were within the range of 80-125%. Results showed an earlier C max which might traduce in faster onset of action for solution formulation. However, criteria for bioequivalence were met for AUC 0-t , and AUC 0-∞ . All measured dexketoprofen-trometamol concentrations in this study were within a safe therapeutic range, and no adverse events were reported.
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