Bioequivalence Study of Escitalopram Tablets 10 mg
Status:
Completed
Trial end date:
2010-05-19
Target enrollment:
Participant gender:
Summary
The objective of this study was to confirm if two formulations of escitalopram tablets are
bioequivalent.
Test product was escitalopram (10 mg; GlaxoSmithKline) and reference product Lexapro® (10 mg
escitalopram; Lundbeck). 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 26 healthy volunteers, male 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.