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NCT00649194 · ClinicalTrials.gov registry record · Phase 1
Food Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Tablets 20 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT00649194 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 72 participants.
The verdict
NCT00649194, 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 relative to Eisai's Aciphex® delayed-release 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fed conditions.
Interventions
- DRUG Aciphex® Tablets 20 mg
- DRUG Rabeprazole Sodium Delayed-Release Tablets 20 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2003-08 |
| Est. Completion | 2003-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00649194
The ClinicalTrials.gov registry entry for NCT00649194 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 Aciphex® Tablets 20 mg is the first listed.
NCT00649194 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00649194 about?
NCT00649194 is a clinical study titled "Food Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Tablets 20 mg". The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium delayed-release 20 mg tablets relative to Eisai's Aciphex® delayed-release 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 NCT00649194?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2003-08. Estimated completion is 2003-08.
What interventions are being tested in trial NCT00649194?
The interventions under investigation include: Aciphex® Tablets 20 mg (DRUG), Rabeprazole Sodium Delayed-Release Tablets 20 mg (DRUG).
Who is sponsoring clinical trial NCT00649194?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
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