The objective of this study was to confirm if two formulations of montelukast tablets are bioequivalent. Test product was Montelukast (5 mg chewable tablets; GlaxoSmithKline) and reference product Singulair (5 mg chewable 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
32
Reference product
Test product
Peak Plasma Concentration (CMAX) of montelukast
Pharmacokinetics
Time frame: 0.0, 0.5, 0.75, 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, and 22 hours postdosage
Area under the plasma concentration versus time curve (AUC) of montelukast
Pharmacokinetics
Time frame: 0.0, 0.5, 0.75, 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, and 22 hours postdosage
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