Bioequivalence Study of Sodium Divalproate Tablets 500 mg

April 11, 2019 updated by: Tecnoquimicas
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be a single-center, open-label, four-period, two-treatment, two-sequence, randomized, single-dose, crossover study. 30 healthy adults will be randomized to receive a single dose (500 mg) of the test formulation of valproic acid and reference formulation of valproic acid separately in each treatment period. There will be two treatment sequences (AB, BA) and a 7 day washout between the two treatment periods.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Chía, Colombia
        • Universidad de la Sabana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and Women from 18 to 50 years old
  • Diagnosed as healthy after a clinical examination
  • BMI from 18 to 30 kg/m2
  • Not smoking for at least 3 months
  • To sign the informed consent
  • Not having participated in a similar study for at least 4 months

Exclusion Criteria:

  • Renal, cardiac immunological, dermatological, endocrine, gastrointestinal, neurological or psychiatric condition
  • Hematologic disorders, specially anemia and polycythemia
  • Permanent or temporal pharmacological therapy, prescribed or not
  • Smoking for the last 3 months
  • Alcohol drinker more than once a week
  • Drug abuse
  • Drug hypersensitivity
  • Angioedema or anaphylaxis history
  • Pregnancy or breast-feeding
  • HIV o Hepatitis B diagnosed
  • Blood donor in the past 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Test Formulation of Valproic Acid
Valproic Acid tablets 500 mg Single dose administered in dosing period 1 or 2
Drug: Valproic Acid 500 MG
Administration of 500 mg of Valproic Acid
ACTIVE_COMPARATOR: Reference Formulation of Valproic Acid
Valcote tablets 500 mg Single dose administered in dosing period 1 or 2
Drug: Valcote 500 mg
Administration of 500 mg of Valproic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(AUC) Area Under the Curve 0-48
Time Frame: From 0 to 48 hours
0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours
From 0 to 48 hours
Cmax
Time Frame: From 0 to 48 hours
0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours
From 0 to 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tmax
Time Frame: From 0 to 48 hours
0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours
From 0 to 48 hours
Kel
Time Frame: From 0 to 48 hours
0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours
From 0 to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tecnoquimicas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 17, 2017

Primary Completion (ACTUAL)

July 31, 2018

Study Completion (ACTUAL)

February 12, 2019

Study Registration Dates

First Submitted

April 11, 2019

First Submitted That Met QC Criteria

April 11, 2019

First Posted (ACTUAL)

April 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 11, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Versión 1- BIO 088

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Valproic Acid 500 MG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe