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NCT01184391 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of Divalproex Sodium Delayed-Release Tablets, 500 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01184391: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT01184391 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01184391, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's divalproex sodium-delayed-release tablets 500 mg tablets to Abbott's Depakote® 500 mg tablets following a single, oral 500 mg (1 x 500 mg) dose administration under fasting conditions.
Primary Outcome
Maximum plasma concentration (micrograms/mL)
Interventions
- DRUG DEPAKOTE® Tablets, 500 MG
- DRUG DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2007-07 |
| Est. Completion | 2007-08 |
| Phase | Phase 1 |
What the finished NCT01184391 record still lists
NCT01184391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which DEPAKOTE® Tablets, 500 MG is the first listed.
NCT01184391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01184391 about?
NCT01184391 is a clinical study titled "Bioequivalence Study of Divalproex Sodium Delayed-Release Tablets, 500 mg". The objective of this study was to investigate the bioequivalence of Mylan's divalproex sodium-delayed-release tablets 500 mg tablets to Abbott's Depakote® 500 mg tablets following a single, oral 500 mg (1 x 500 mg) dose administration under fasting conditions.
What is the current status of trial NCT01184391?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2007-07. Estimated completion is 2007-08.
What interventions are being tested in trial NCT01184391?
The interventions under investigation include: DEPAKOTE® Tablets, 500 MG (DRUG), DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG (DRUG).
Who is sponsoring clinical trial NCT01184391?
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 NCT01184391's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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