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NCT00835640 · ClinicalTrials.gov registry record · Phase 1
Fexofenadine Hydrochloride 180 mg Tablets Under Non-Fasting Conditions
A Phase 1 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00835640: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.
NCT00835640 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00835640, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
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 fed conditions.
Primary Outcome
Bioequivalence based on Cmax.
Interventions
- DRUG Fexofenadine 180 mg tablets
- DRUG ALLEGRA® 180 mg tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2002-01 |
| Est. Completion | 2002-01 |
| Phase | Phase 1 |
What the finished NCT00835640 record still lists
NCT00835640 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Fexofenadine 180 mg tablets is the first listed.
NCT00835640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00835640 about?
NCT00835640 is a clinical study titled "Fexofenadine Hydrochloride 180 mg Tablets Under Non-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 NCT00835640?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2002-01. Estimated completion is 2002-01.
What interventions are being tested in trial NCT00835640?
The interventions under investigation include: Fexofenadine 180 mg tablets (DRUG), ALLEGRA® 180 mg tablets (DRUG).
Who is sponsoring clinical trial NCT00835640?
This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00835640's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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