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NCT00974441 · ClinicalTrials.gov registry record · Phase 1

Divalproex Sodium 500 mg Extended Release Tablets Under Fasting Conditions

A Phase 1 study, sponsored by Teva Pharmaceuticals USA.

Completed
Registry status
Phase 1
Development phase
48
Enrollment target

NCT00974441: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.

NCT00974441 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 48 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00974441, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.

COMPLETED
Registry status
Phase 1
Development phase
48 participants
Enrollment target

Study Summary

This study will compare the relative bioavailability (rate and extent of absorption) of 500 mg Divalproex Sodium (equivalent to 500 mg Valproic Acid) Extended Release Tablets with that of Depakote® ER Tablets following a single oral dose (1 x 500 mg tablet) in healthy adult subjects administered under fasting conditions.

Interventions

  • DRUG Divalproex Sodium
  • DRUG Depakote®

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2006-08
Est. Completion 2006-09
Phase Phase 1

Sponsor

Teva Pharmaceuticals USA

83 total trials

What the Registry Record Tells You About NCT00974441

The ClinicalTrials.gov registry entry for NCT00974441 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Pharmaceuticals USA, which has 83 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Divalproex Sodium is the first listed.

NCT00974441 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00974441 about?

NCT00974441 is a clinical study titled "Divalproex Sodium 500 mg Extended Release Tablets Under Fasting Conditions". This study will compare the relative bioavailability (rate and extent of absorption) of 500 mg Divalproex Sodium (equivalent to 500 mg Valproic Acid) Extended Release Tablets with that of Depakote® ER Tablets following a single oral dose (1 x 500 mg tablet) in healthy adult subjects administered und...

What is the current status of trial NCT00974441?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2006-08. Estimated completion is 2006-09.

What interventions are being tested in trial NCT00974441?

The interventions under investigation include: Divalproex Sodium (DRUG), Depakote® (DRUG).

Who is sponsoring clinical trial NCT00974441?

This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.