CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 60 enrolled
Drug / intervention
Fexofenadine 180 mg tablets +1 moredrug
Likely dose
Fexofenadine 180 mg tablet, single doseAI-extracted
Key inclusion· 3
  • ✓Healthy, non-smoking men and women aged 18–55 years inclusive at time of dosing
  • ✓Body mass index (BMI) ≤30
  • ✓Female volunteers must be postmenopausal for ≥1 year, surgically sterile, or practicing acceptable birth control
Key exclusion· 16
  • ✕Recent history of drug or alcohol addiction or abuse
  • ✕Clinically significant disorder involving cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system or psychiatric disease
  • ✕Positive hepatitis B surface antigen, hepatitis C antibody, or HIV antibody screening
  • ✕Positive drug abuse screen

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00835276
NCT00835276Phase 1Completed
CompareCT.gov

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

Teva Pharmaceuticals USA·interventional·Posted Feb 3, 2009·Updated Aug 20, 2009

In Brief

A Phase 1 clinical trial evaluating Fexofenadine 180 mg tablets and ALLEGRA® 180 mg tablets for Healthy. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 3, 2009
Enrollment StartMar 1, 2002
Primary CompletionMar 1, 2002
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago

Interventions

Fexofenadine 180 mg tabletsdrug

1 x 180 mg

ALLEGRA® 180 mg tabletsdrug

1 x 180 mg