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NCT00648804 · ClinicalTrials.gov registry record · Phase 1
Food Study of Ondansetron Orally Disintegrating Tablets 8 mg to Zofran ODT® Tablets 8 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT00648804 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 28 participants.
The verdict
NCT00648804, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's ondansetron orally disintegrating 8 mg tablets to GlaxoSmithKline's Zofran ODT® 8 mg tablets following a single, oral 8 mg (1 x 8 mg) dose administered under fed conditions.
Interventions
- DRUG Ondansetron Orally Disintegrating Tablets 8 mg
- DRUG Zofran ODT® Tablets 8 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2005-07 |
| Est. Completion | 2005-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00648804
The ClinicalTrials.gov registry entry for NCT00648804 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 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 Ondansetron Orally Disintegrating Tablets 8 mg is the first listed.
NCT00648804 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00648804 about?
NCT00648804 is a clinical study titled "Food Study of Ondansetron Orally Disintegrating Tablets 8 mg to Zofran ODT® Tablets 8 mg". The objective of this study was to investigate the bioequivalence of Mylan's ondansetron orally disintegrating 8 mg tablets to GlaxoSmithKline's Zofran ODT® 8 mg tablets following a single, oral 8 mg (1 x 8 mg) dose administered under fed conditions.
What is the current status of trial NCT00648804?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2005-07. Estimated completion is 2005-07.
What interventions are being tested in trial NCT00648804?
The interventions under investigation include: Ondansetron Orally Disintegrating Tablets 8 mg (DRUG), Zofran ODT® Tablets 8 mg (DRUG).
Who is sponsoring clinical trial NCT00648804?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
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