Asthma Clinical Trial
Official title:
Open, Two Periods, Two Treatments, Two Sequences, Cross-over, Randomized Study With Single Dosage of Two Oral Preparations of Chewable Tablets of Montelukast 5 mg (Product of GlaxoSmithKline México, S.A. de C.V. vs. Singulair™, Merck Sharp & Dohme de México, S.A. de C.V.) in Fasting Healthy Volunteers
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.
n/a
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