Bioequivalence Study of Sodium Divalproate Tablets 500 mg

Bioequivalence Study of Sodium Divalproate Tablets 500 mg

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.

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.

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