NCT03914534

Bioequivalence Study of Sodium Divalproate Tablets 500 mg

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Tecnoquimicas · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Valproic Acid 500 MG	Administration of 500 mg of Valproic Acid
DRUG	Valcote 500 mg	Administration of 500 mg of Valproic Acid

Timeline

• Start date: 2017-04-17
• Primary completion: 2018-07-31
• Completion: 2019-02-12
• First posted: 2019-04-16
• Last updated: 2019-04-16

Locations

1 site across 1 country: Colombia