The objective of this study was to confirm if two formulations of nimesulide tablets are bioequivalent. Test product was Eskaflam® (Nimesulide 100 mg tablets; GlaxoSmithKline) and reference product Mesulid® (Nimesulide 100 mg tablets; Syntex for Productos Roche). The single dosage was one tablet. The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. The population was composed of 28 healthy volunteers, both genders, adults between 18-40 years. The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
28
Reference product
Test product
Peak Plasma Concentration (CMAX) of nimesulide
Pharmacokinetics
Time frame: 0.0, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 15.0, 18.0 and 24.0 postdosage
Area under the plasma concentration versus time curve (AUC) of nimesulide
Pharmacokinetics
Time frame: 0.0, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 15.0, 18.0 and 24.0 postdosage
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.