Pain Clinical Trial
Official title:
Open, Two Periods, Two Treatments, Two Sequences, Cross-over, Randomized Study With Single Dosage of Two Oral Preparations Containing Nimesulide 100 mg(Eskaflam®, GlaxoSmithKline México, S.A. de C.V. vs. Mesulid®, Producto de Roche, S.A. de C.V.) in Fasting Healthy Volunteers
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.
n/a
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