Bioequivalence Study of Sodium Divalproate Tablets 500 mg

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Valproic Acid 500 MG; Drug: Valcote 500 mg

• Registration Number: NCT03914534
• Lead Sponsor: Tecnoquimicas

Brief Summary

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

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 Timeline

• Study Start: 2017-04-17
• Primary Completion: 2018-07-31
• Study Completion: 2019-02-12
• Status Verified: 2019-04
• Study First Submitted: 2019-04-11
• Study First Submitted QC: 2019-04-11
• Last Update Submitted: 2019-04-11
• Study First Posted: 2019-04-16
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test Formulation of Valproic Acid	Valproic Acid 500 MG	Valproic Acid tablets 500 mg Single dose administered in dosing period 1 or 2
Reference Formulation of Valproic Acid	Valcote 500 mg	Valcote tablets 500 mg Single dose administered in dosing period 1 or 2

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Kel	From 0 to 48 hours	0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours
Tmax	From 0 to 48 hours	0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours

Trial Locations

Locations (1)

Universidad de la Sabana; 🇨🇴 Chía, Colombia