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NCT00974012 · ClinicalTrials.gov registry record · Phase 1

Divalproex Sodium 500 mg Extended Release Tablets Under Non-Fasting Conditions

A Phase 1 study of Healthy, sponsored by Teva Pharmaceuticals U.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target
1
Study location

NCT00974012 is a Phase 1 study of Healthy that has completed, run by Teva Pharmaceuticals U. The registered enrollment target is 24 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00974012, a Phase 1 study of Healthy, has completed, sponsored by Teva Pharmaceuticals U.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target
1
Study location

Study Summary

This study was designed to compare the relative bioavailability (rate and extent of absorption) of Divalproex Sodium ER Tablets 500 mg with that of Depakote® ER Tablets 500 mg following a single, oral dose (1 x 500 mg extended release tablet) administered to healthy, adult subjects under non-fasting conditions.

Conditions Studied

Interventions

  • DRUG Divalproex Sodium
  • DRUG Depakote®

Study Locations (1)

Minnesota

  • PRACS Institute, Ltd. - East Grand Forks

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2006-10
Est. Completion 2006-10
Phase Phase 1

Sponsor

Teva Pharmaceuticals U

19 total trials

What the Registry Record Tells You About NCT00974012

The ClinicalTrials.gov registry entry for NCT00974012 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The listed sponsor is Teva Pharmaceuticals U, which has 19 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Divalproex Sodium is the first listed.

NCT00974012 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT00974012 about?

NCT00974012 is a clinical study titled "Divalproex Sodium 500 mg Extended Release Tablets Under Non-Fasting Conditions". This study was designed to compare the relative bioavailability (rate and extent of absorption) of Divalproex Sodium ER Tablets 500 mg with that of Depakote® ER Tablets 500 mg following a single, oral dose (1 x 500 mg extended release tablet) administered to healthy, adult subjects under non-fasting...

What is the current status of trial NCT00974012?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2006-10. Estimated completion is 2006-10.

What conditions does trial NCT00974012 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00974012?

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

Who is sponsoring clinical trial NCT00974012?

This trial is sponsored by Teva Pharmaceuticals U, which has 19 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00974012 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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, or report a data error.