Bioequivalence Study of Sodium Divalproate Tablets 500 mg

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-17

Study Completion Date

2019-02-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bioequivalence Study of Divalproex Sodium Delayed-Release Tablets, 500 mg

NCT01184391

Healthy

COMPLETED PHASE1

Fed Bioequivalence Study of Divalproex Sodium Delayed-Release Tablets, 500 mg

NCT01183676

Healthy

COMPLETED PHASE1

Food Study of Divalproex Sodium Extended-Release Tablets 500 mg to Depakote ER® Tablets 500 mg

NCT00648076

Healthy

COMPLETED PHASE1

Bioequivalence Study of Divalproex Sodium ER Tablets, 500 mg Under Fed Conditions

NCT01581788

Healthy

COMPLETED PHASE1

Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition

NCT01513681

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test Formulation of Valproic Acid

Valproic Acid tablets 500 mg Single dose administered in dosing period 1 or 2

Group Type EXPERIMENTAL

Valproic Acid 500 MG

Intervention Type DRUG

Administration of 500 mg of Valproic Acid

Reference Formulation of Valproic Acid

Valcote tablets 500 mg Single dose administered in dosing period 1 or 2

Group Type ACTIVE_COMPARATOR

Valcote 500 mg

Intervention Type DRUG

Administration of 500 mg of Valproic Acid

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Valproic Acid 500 MG

Administration of 500 mg of Valproic Acid

Intervention Type DRUG

Valcote 500 mg

Administration of 500 mg of Valproic Acid

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes