Bioequivalence Study of Sodium Divalproate Tablets 500 mg

Tecnoquimicas

Status and phase

Completed

Phase 4

Conditions

Healthy

Treatments

Drug: Valproic Acid 500 MG

Drug: Valcote 500 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT03914534

Versión 1- BIO 088

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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