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NCT01046084 · ClinicalTrials.gov registry record · Phase 1

Lansoprazole 30 mg DR Capsule Replicate Food Study

A Phase 1 study, sponsored by Teva Pharmaceuticals USA.

Completed
Registry status
Phase 1
Development phase
50
Enrollment target

NCT01046084: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.

NCT01046084 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01046084, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.

COMPLETED
Registry status
Phase 1
Development phase
50 participants
Enrollment target

Study Summary

The object of this study is to compare the relative bioavailability of lansoprazole 30 mg delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP Pharmaceuticals, Inc.) in healthy, adult, subjects under non-fasting conditions.

Primary Outcome

Bioequivalence based on Cmax.

Interventions

  • DRUG Lansoprazole
  • DRUG Prevacid®

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2003-08
Est. Completion 2003-09
Phase Phase 1
Teva Pharmaceuticals USA

83 total trials

What the finished NCT01046084 record still lists

NCT01046084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).

The record links to 0 conditions, and to 2 interventions - of which Lansoprazole is the first listed.

NCT01046084 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01046084 about?

NCT01046084 is a clinical study titled "Lansoprazole 30 mg DR Capsule Replicate Food Study". The object of this study is to compare the relative bioavailability of lansoprazole 30 mg delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP Pharmaceuticals, Inc.) in healthy, adult, subject...

What is the current status of trial NCT01046084?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2003-08. Estimated completion is 2003-09.

What interventions are being tested in trial NCT01046084?

The interventions under investigation include: Lansoprazole (DRUG), Prevacid® (DRUG).

Who is sponsoring clinical trial NCT01046084?

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 NCT01046084's enrollment target sits among peer trials

50 973rd of 2000 higher than 984 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 NCT01046084, the US trial registry maintained by the National Library of Medicine. NCT01046084 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.