NCT00835276

Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions

A Relative Bioavailability Study of 180 mg Fexofenadine Hydrochloride Tablets Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will compare the relative bioavailability (rate and extent of absorption) of 180 mg Fexofenadine Hydrochloride tablets manufactured for TEVA Pharmaceuticals Industries, Ltd. with that of 180 mg ALLEGRA® Tablets by Aventis Pharmaceuticals, Inc. following a single oral dose (1 x 180 mg tablet) in healthy adult volunteers under fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Fexofenadine 180 mg tablets	1 x 180 mg
DRUG	ALLEGRA® 180 mg tablets	1 x 180 mg

Timeline

• Start date: 2002-03-01
• Primary completion: 2002-03-01
• Completion: 2002-03-01
• First posted: 2009-02-03
• Last updated: 2009-08-20
• Results posted: 2009-08-04

Locations

1 site across 1 country: United States