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NCT00834340 · ClinicalTrials.gov registry record · Phase 1

Glimepiride 4 mg Tablets Under Fasting Conditions

A Phase 1 study, sponsored by Teva Pharmaceuticals USA.

Completed
Registry status
Phase 1
Development phase
32
Enrollment target

NCT00834340: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.

NCT00834340 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00834340, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target

Study Summary

The objective of this study is to compare the relative bioavailability of glimepiride 4 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of AMARYL® tablets (Aventis) in healthy, adult, non-smoking subjects under fasting conditions.

Primary Outcome

Bioequivalence based on Cmax

Interventions

  • DRUG Glimepiride 4 mg Tablets
  • DRUG AMARYL® 4 mg Tablets

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2003-02
Est. Completion 2003-03
Phase Phase 1
Teva Pharmaceuticals USA

83 total trials

What the finished NCT00834340 record still lists

NCT00834340 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 2 interventions - of which Glimepiride 4 mg Tablets is the first listed.

NCT00834340 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00834340 about?

NCT00834340 is a clinical study titled "Glimepiride 4 mg Tablets Under Fasting Conditions". The objective of this study is to compare the relative bioavailability of glimepiride 4 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of AMARYL® tablets (Aventis) in healthy, adult, non-smoking subjects under fasting condition...

What is the current status of trial NCT00834340?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2003-02. Estimated completion is 2003-03.

What interventions are being tested in trial NCT00834340?

The interventions under investigation include: Glimepiride 4 mg Tablets (DRUG), AMARYL® 4 mg Tablets (DRUG).

Who is sponsoring clinical trial NCT00834340?

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 NCT00834340's enrollment target sits among peer trials

32 1296th of 2000 higher than 679 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 NCT00834340, the US trial registry maintained by the National Library of Medicine. NCT00834340 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.