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NCT00648349 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Delayed-Release Tablets 20 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT00648349: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00648349 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00648349, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium delayed-release 20 mg tablets to Eisai's Aciphex® delayed-release 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fasting conditions.
Interventions
- DRUG Rabeprazole Sodium Delayed-Release Tablets 20 mg
- DRUG Aciphex® Delayed-Release Tablets 20 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2003-05 |
| Est. Completion | 2003-06 |
| Phase | Phase 1 |
What the finished NCT00648349 record still lists
NCT00648349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 2 interventions - of which Rabeprazole Sodium Delayed-Release Tablets 20 mg is the first listed.
NCT00648349 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00648349 about?
NCT00648349 is a clinical study titled "Fasting Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Delayed-Release Tablets 20 mg". The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium delayed-release 20 mg tablets to Eisai's Aciphex® delayed-release 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fasting conditions.
What is the current status of trial NCT00648349?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2003-05. Estimated completion is 2003-06.
What interventions are being tested in trial NCT00648349?
The interventions under investigation include: Rabeprazole Sodium Delayed-Release Tablets 20 mg (DRUG), Aciphex® Delayed-Release Tablets 20 mg (DRUG).
Who is sponsoring clinical trial NCT00648349?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00648349's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 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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