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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 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 17 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01184391
The ClinicalTrials.gov registry entry for NCT01184391 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 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 DEPAKOTE® Tablets, 500 MG is the first listed.
NCT01184391 reports 0 study locations.
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.
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