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

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. According to ClinicalTrials.gov, the official US trial registry.

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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
Teva Pharmaceuticals U

19 total trials

What the finished NCT00974012 record still lists

NCT00974012 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 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower).

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 a single indexed study location in 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.

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00974012's enrollment target sits among peer trials

24 791st of 1090 higher than 254 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy 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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Source: ClinicalTrials.gov NCT00974012, the US trial registry maintained by the National Library of Medicine. NCT00974012 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.