Clinical Trials Directory

Trials / Completed

CompletedNCT00648661

Food Study of Escitalopram Oxalate Tablets 20 mg to Lexapro® Tablets 20 mg

Single-Dose Food In Vivo Bioequivalence Study of Escitalopram Oxalate Tablets (20 mg; Mylan) to Lexapro® Tablets (20 mg; Forest) in Healthy Volunteers

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
35 (actual)
Sponsor
Mylan Pharmaceuticals Inc · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's escitalopram oxalate 20 mg tablets to Forest's Lexapro® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administered under fed conditions.

Conditions

Interventions

TypeNameDescription
DRUGEscitalopram Oxalate Tablets 20 mg20mg, single dose fed
DRUGLexapro® Tablets 20 mg20mg, single dose fed

Timeline

Start date
2004-09-01
Primary completion
2004-10-01
Completion
2004-10-01
First posted
2008-04-01
Last updated
2024-04-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00648661. Inclusion in this directory is not an endorsement.