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NCT00649532 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Ondansetron Tablets 24 mg and Zofran® Tablets 24 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT00649532 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 28 participants.
The verdict
NCT00649532, 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 24 mg tablets to GSK's Zofran® 24 mg tablets following a single, oral 24 mg (1 x 24 mg) dose administered under fasting conditions.
Interventions
- DRUG Ondansetron Tablets 24 mg
- DRUG Zofran® Tablets 24 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2003-07 |
| Est. Completion | 2003-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00649532
The ClinicalTrials.gov registry entry for NCT00649532 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 Tablets 24 mg is the first listed.
NCT00649532 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00649532 about?
NCT00649532 is a clinical study titled "Fasting Study of Ondansetron Tablets 24 mg and Zofran® Tablets 24 mg". The objective of this study was to investigate the bioequivalence of Mylan's ondansetron 24 mg tablets to GSK's Zofran® 24 mg tablets following a single, oral 24 mg (1 x 24 mg) dose administered under fasting conditions.
What is the current status of trial NCT00649532?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2003-07. Estimated completion is 2003-07.
What interventions are being tested in trial NCT00649532?
The interventions under investigation include: Ondansetron Tablets 24 mg (DRUG), Zofran® Tablets 24 mg (DRUG).
Who is sponsoring clinical trial NCT00649532?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
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