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NCT00834639 · ClinicalTrials.gov registry record · Phase 1
Divalproex Sodium Delayed-Release Tablets Under Fasting Conditions
A Phase 1 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00834639: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.
NCT00834639 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00834639, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study will compare the relative bioavailability of 500 mg Divalproex Sodium Delayed-Release Tablets with that of 500 mg Depakote® Tablets following a single oral dose (1 x 500 mg tablets)in healthy subjects under fasting conditions.
Primary Outcome
Bioequivalence based on Cmax.
Interventions
- DRUG divalproex sodium
- DRUG Depakote®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2003-09 |
| Est. Completion | 2003-09 |
| Phase | Phase 1 |
What the finished NCT00834639 record still lists
NCT00834639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which divalproex sodium is the first listed.
NCT00834639 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00834639 about?
NCT00834639 is a clinical study titled "Divalproex Sodium Delayed-Release Tablets Under Fasting Conditions". This study will compare the relative bioavailability of 500 mg Divalproex Sodium Delayed-Release Tablets with that of 500 mg Depakote® Tablets following a single oral dose (1 x 500 mg tablets)in healthy subjects under fasting conditions.
What is the current status of trial NCT00834639?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2003-09. Estimated completion is 2003-09.
What interventions are being tested in trial NCT00834639?
The interventions under investigation include: divalproex sodium (DRUG), Depakote® (DRUG).
Who is sponsoring clinical trial NCT00834639?
This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00834639's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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