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Bioequivalence Study of Sodium Divalproate Tablets 500 mg

NCT03914534 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-04-16

No results posted yet for this study

Summary

The objective of this study is to establish the bioequivalence of two valproic acid formulations through the estimation of valproic acid in plasma samples, according to Food and Drugs Administration (FDA), World Health Organization (WHO) and Colombian National Vigilance Institute for Drugs and Food (INVIMA) guidelines.

Conditions

  • Healthy

Interventions

DRUG

Valproic Acid 500 MG

Administration of 500 mg of Valproic Acid

DRUG

Valcote 500 mg

Administration of 500 mg of Valproic Acid

Sponsors & Collaborators

  • Tecnoquimicas

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-17
Primary Completion
2018-07-31
Completion
2019-02-12

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03914534 on ClinicalTrials.gov