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Bioequivalence Study of Escitalopram Tablets 10 mg

NCT01745601 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-06-16

No results posted yet for this study

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.

Conditions

  • Anxiety Disorders

Interventions

DRUG

escitalopram 10 mg

Reference product

DRUG

escitalopram 10 mg

Test product

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-04
Primary Completion
2010-05-19
Completion
2010-05-19

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01745601 on ClinicalTrials.gov