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Bioequivalence Study of Sodium Divalproate Tablets 500 mg

Healthy Clinical Trial

Official title:
Bioequivalence Study of Sodium Divalproate Tablets 500 mg

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03914534
Study type Interventional
Source Tecnoquimicas
Contact
Status Completed
Phase Phase 4
Start date April 17, 2017
Completion date February 12, 2019
View Details
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