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NCT00647985 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target

NCT00647985: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.

NCT00647985 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00647985, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
28 participants
Enrollment target

Study 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 fed conditions.

Interventions

  • DRUG Fexofenadine Tablets 180 mg
  • DRUG Allegra® Tablets 180 mg

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2003-11
Est. Completion 2003-11
Phase Phase 1
Mylan Pharmaceuticals

146 total trials

What the finished NCT00647985 record still lists

NCT00647985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 2 interventions - of which Fexofenadine Tablets 180 mg is the first listed.

NCT00647985 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00647985 about?

NCT00647985 is a clinical study titled "Food Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mg". 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 fed conditions.

What is the current status of trial NCT00647985?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2003-11. Estimated completion is 2003-11.

What interventions are being tested in trial NCT00647985?

The interventions under investigation include: Fexofenadine Tablets 180 mg (DRUG), Allegra® Tablets 180 mg (DRUG).

Who is sponsoring clinical trial NCT00647985?

This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00647985's enrollment target sits among peer trials

28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT00647985, the US trial registry maintained by the National Library of Medicine. NCT00647985 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.