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NCT00647712 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Divalproex Sodium Extended-Release Tablets 500 mg to Depakote ER® Tablets 500 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT00647712: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00647712 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00647712, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's divalproex sodium 500 mg extended-release tablets to Abbott's Depakote ER® 500 mg tablets following a single, oral 500 mg (1 x 500 mg) dose administered under fasting conditions.
Interventions
- DRUG Divalproex Sodium Extended-Release Tablets 500 mg
- DRUG Depakote ER® Tablets 500 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2004-12 |
| Est. Completion | 2004-12 |
| Phase | Phase 1 |
What the finished NCT00647712 record still lists
NCT00647712 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Divalproex Sodium Extended-Release Tablets 500 mg is the first listed.
NCT00647712 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00647712 about?
NCT00647712 is a clinical study titled "Fasting Study of Divalproex Sodium Extended-Release Tablets 500 mg to Depakote ER® Tablets 500 mg". The objective of this study was to investigate the bioequivalence of Mylan's divalproex sodium 500 mg extended-release tablets to Abbott's Depakote ER® 500 mg tablets following a single, oral 500 mg (1 x 500 mg) dose administered under fasting conditions.
What is the current status of trial NCT00647712?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2004-12. Estimated completion is 2004-12.
What interventions are being tested in trial NCT00647712?
The interventions under investigation include: Divalproex Sodium Extended-Release Tablets 500 mg (DRUG), Depakote ER® Tablets 500 mg (DRUG).
Who is sponsoring clinical trial NCT00647712?
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 NCT00647712's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 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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