Bioequivalence Study of Sodium Divalproate Tablets 500 mg

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Bioequivalence Study of Sodium Divalproate Tablets 500 mg

Conditions
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Healthy

Intervention / Treatment
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* Drug: Valproic Acid 500 MG
* Drug: Valcote 500 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Formulation of Valproic Acid<br>Valproic Acid tablets 500 mg Single dose administered in dosing period 1 or 2 | Drug: Valproic Acid 500 MG<br>* Administration of 500 mg of Valproic Acid<br>|
| Active Comparator: Reference Formulation of Valproic Acid<br>Valcote tablets 500 mg Single dose administered in dosing period 1 or 2 | Drug: Valcote 500 mg<br>* Administration of 500 mg of Valproic Acid<br>|

What is the study measuring?
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Primary Outcome Measures

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