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NCT00650052 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 107
- Enrollment target
NCT00650052: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00650052 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 107 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00650052, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 107 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's zonisamide, 100 mg capsules to Elan's Zonegran® 100 mg capsules following a single, oral 100 mg (1 x 100 mg) dose administered under fasting conditions.
Interventions
- DRUG Zonisamide Capsules 100 mg
- DRUG Zonegran® Capsules 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2003-11 |
| Est. Completion | 2003-12 |
| Phase | Phase 1 |
What the finished NCT00650052 record still lists
NCT00650052 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% higher).
The record links to 0 conditions, and to 2 interventions - of which Zonisamide Capsules 100 mg is the first listed.
NCT00650052 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00650052 about?
NCT00650052 is a clinical study titled "Fasting Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg". The objective of this study was to investigate the bioequivalence of Mylan's zonisamide, 100 mg capsules to Elan's Zonegran® 100 mg capsules following a single, oral 100 mg (1 x 100 mg) dose administered under fasting conditions.
What is the current status of trial NCT00650052?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 107 participants. The study started on 2003-11. Estimated completion is 2003-12.
What interventions are being tested in trial NCT00650052?
The interventions under investigation include: Zonisamide Capsules 100 mg (DRUG), Zonegran® Capsules 100 mg (DRUG).
Who is sponsoring clinical trial NCT00650052?
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 NCT00650052's enrollment target sits among peer trials
107 531st of 2000 higher than 1,470 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
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