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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 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 107 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00650052
The ClinicalTrials.gov registry entry for NCT00650052 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 107 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 Zonisamide Capsules 100 mg is the first listed.
NCT00650052 reports 0 study locations.
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.
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