The objective of this study was to confirm if two formulations of montelukast tablets are
bioequivalent.
Test product was Montelukast (10 mg tablets; GlaxoSmithKline) and reference product Singulair
(10 mg tablets; Merck Sharp & Dohme). 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 32 healthy volunteers, both genders, adults between 18-50
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.