Clinical Trials Directory

Trials / Completed

CompletedNCT00649376

Fasting Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mg

Single-Dose Fasting In Vivo Bioequivalence Study of Fexofenadine Tablets (180 mg; Mylan) and Allegra® Tablets (180 mg; Aventis) in Healthy Adult Volunteers

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
68 (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 fexofenadine 180 mg tablets to Aventis' Allegra® 180 mg tablets following a single, oral 180 mg (1 x 180 mg) dose administered under fasting conditions.

Conditions

Interventions

TypeNameDescription
DRUGFexofenadine Tablets 180 mg180mg, single dose fasting
DRUGAllegra® Tablets 180 mg180mg, single dose fasting

Timeline

Start date
2003-10-01
Primary completion
2003-11-01
Completion
2003-11-01
First posted
2008-04-01
Last updated
2024-04-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00649376. Inclusion in this directory is not an endorsement.