Bioequivalence Study of Escitalopram Tablets 10 mg

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Anxiety Disorders

Clinical Trial Details

NCT number	NCT01745601
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 1
Start date	May 4, 2010
Completion date	May 19, 2010

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