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NCT00834418 · ClinicalTrials.gov registry record · Phase 1

Leflunomide 20 mg Tablets Under Fasting Conditions

A Phase 1 study, sponsored by Teva Pharmaceuticals USA.

Completed
Registry status
Phase 1
Development phase
84
Enrollment target

NCT00834418: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.

NCT00834418 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 84 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00834418, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.

COMPLETED
Registry status
Phase 1
Development phase
84 participants
Enrollment target

Study Summary

This study will compare the relative bioavailability (rate and extent of absorption) of 20 mg Leflunomide Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 20 mg ARAVA™ Tablets by Aventis Pharmaceuticals, Inc. following a single oral dose (1 x 20 mg tablet) in healthy adult subjects under fasting conditions.

Primary Outcome

Bioequivalence based on Cmax

Interventions

  • DRUG Leflunomide 20 mg Tablets
  • DRUG ARAVA™ 20 mg Tablets

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2002-06
Est. Completion 2002-07
Phase Phase 1
Teva Pharmaceuticals USA

83 total trials

What the finished NCT00834418 record still lists

NCT00834418 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher).

The record links to 0 conditions, and to 2 interventions - of which Leflunomide 20 mg Tablets is the first listed.

NCT00834418 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00834418 about?

NCT00834418 is a clinical study titled "Leflunomide 20 mg Tablets Under Fasting Conditions". This study will compare the relative bioavailability (rate and extent of absorption) of 20 mg Leflunomide Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 20 mg ARAVA™ Tablets by Aventis Pharmaceuticals, Inc. following a single oral dose (1 x 20 mg tablet) in healthy adult subjects unde...

What is the current status of trial NCT00834418?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2002-06. Estimated completion is 2002-07.

What interventions are being tested in trial NCT00834418?

The interventions under investigation include: Leflunomide 20 mg Tablets (DRUG), ARAVA™ 20 mg Tablets (DRUG).

Who is sponsoring clinical trial NCT00834418?

This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00834418's enrollment target sits among peer trials

84 659th of 2000 higher than 1,336 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 NCT00834418, the US trial registry maintained by the National Library of Medicine. NCT00834418 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.