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Bioequivalence Study of Sodium Divalproate Tablets 500 mg

2019-04-17 12:55:22 | BioPortfolio

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.

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

Conditions

Healthy

Intervention

Valproic Acid 500 MG, Valcote 500 mg

Location

Universidad de la Sabana
Chía
Colombia

Status

Completed

Source

Tecnoquimicas

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-04-17T12:55:22-0400

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