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NCT00835276 · ClinicalTrials.gov registry record · Phase 1

Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions

A Phase 1 study of Healthy, sponsored by Teva Pharmaceuticals U.

Completed
Registry status
Phase 1
Development phase
60
Enrollment target
1
Study location

NCT00835276: Completed Phase 1 study of Healthy, sponsored by Teva Pharmaceuticals U.

NCT00835276 is a Phase 1 study of Healthy that has completed, run by Teva Pharmaceuticals U. The registered enrollment target is 60 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00835276, a Phase 1 study of Healthy, has completed, sponsored by Teva Pharmaceuticals U.

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Bioequivalence based on Cmax.

Conditions Studied

Healthy

Interventions

  • DRUG Fexofenadine 180 mg tablets
  • DRUG ALLEGRA® 180 mg tablets

Study Locations (1)

North Dakota

  • PRACS Institute, Ltd. - Fargo

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2002-03
Est. Completion 2002-03
Phase Phase 1
Teva Pharmaceuticals U

19 total trials

What the finished NCT00835276 record still lists

NCT00835276 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower).

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Fexofenadine 180 mg tablets is the first listed.

NCT00835276 reports a single indexed study location in North Dakota.

Frequently Asked Questions

What is clinical trial NCT00835276 about?

NCT00835276 is a clinical study titled "Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions". 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 tabl...

What is the current status of trial NCT00835276?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2002-03. Estimated completion is 2002-03.

What conditions does trial NCT00835276 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00835276?

The interventions under investigation include: Fexofenadine 180 mg tablets (DRUG), ALLEGRA® 180 mg tablets (DRUG).

Who is sponsoring clinical trial NCT00835276?

This trial is sponsored by Teva Pharmaceuticals U, which has 19 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00835276 being conducted?

This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00835276's enrollment target sits among peer trials

60 369th of 1090 higher than 689 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00835276, the US trial registry maintained by the National Library of Medicine. NCT00835276 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.