Status:

COMPLETED

Bioequivalence Study of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions

Lead Sponsor:

Sandoz

Conditions:

Seizures

Eligibility:

MALE

18+ years

Phase:

PHASE1

Brief Summary

The purpose of this study is to demonstrate the bioequivalence of divalproex sodium 125 MG delayed release tablets.

Eligibility Criteria

Inclusion

  • No clinically significant findings on physical examination, medical history or laboratory tests on screening

Exclusion

  • Positive test for HIV or Hepatitis B and C
  • History of sensitivity to valproic acid or related compounds

Key Trial Info

Start Date :

October 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2006

Estimated Enrollment :

28 Patients enrolled

Trial Details

Trial ID

NCT00864006

Start Date

October 1 2006

End Date

October 1 2006

Last Update

March 29 2017

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