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NCT01046253 · ClinicalTrials.gov registry record · Phase 1
Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study
A Phase 1 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT01046253: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.
NCT01046253 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.
The verdict
NCT01046253, 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 fasting conditions with dosing by applesauce-sprinkle method.
Primary Outcome
Bioequivalence based on Cmax.
Interventions
- DRUG Lansoprazole
- DRUG Prevacid®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2004-01 |
| Est. Completion | 2004-01 |
| Phase | Phase 1 |
What the finished NCT01046253 record still lists
NCT01046253 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.
NCT01046253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01046253 about?
NCT01046253 is a clinical study titled "Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle 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 NCT01046253?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2004-01. Estimated completion is 2004-01.
What interventions are being tested in trial NCT01046253?
The interventions under investigation include: Lansoprazole (DRUG), Prevacid® (DRUG).
Who is sponsoring clinical trial NCT01046253?
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 NCT01046253'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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