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NCT00649493 · ClinicalTrials.gov registry record · Phase 1
Fed Study of Rabeprazole Sodium Tablets 20 mg and Aciphex® Tablets 20 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT00649493 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 72 participants.
The verdict
NCT00649493, 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 20 mg tablets to Eisai's Aciphex® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fed conditions.
Interventions
- DRUG Rabeprazole Sodium Tablets 20 mg
- DRUG Aciphex® Tablets 20 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2003-05 |
| Est. Completion | 2003-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00649493
The ClinicalTrials.gov registry entry for NCT00649493 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rabeprazole Sodium Tablets 20 mg is the first listed.
NCT00649493 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00649493 about?
NCT00649493 is a clinical study titled "Fed Study of Rabeprazole Sodium Tablets 20 mg and Aciphex® Tablets 20 mg". The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium 20 mg tablets to Eisai's Aciphex® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fed conditions.
What is the current status of trial NCT00649493?
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 NCT00649493?
The interventions under investigation include: Rabeprazole Sodium Tablets 20 mg (DRUG), Aciphex® Tablets 20 mg (DRUG).
Who is sponsoring clinical trial NCT00649493?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
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