Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00648804 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00648804 record still lists
NCT00648804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Ondansetron Orally Disintegrating Tablets 8 mg is the first listed.
NCT00648804 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00648804's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03471117 · 28 participants · Phase 4
Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients
- NCT03523975 · 28 participants · Phase 1
Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
- NCT03608631 · 28 participants · Phase 1
iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation
- NCT03810651 · 28 participants · Early Phase 1
Pencil Beam Scanning in Patients With Renal Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia