NCT00298857

A Pharmacokinetic Study to Compare the Dosing of Valproic Acid in Subjects With Different Body Weights

An Open-label, Prospective Trial to Determine the Effect(s) of Obesity on the Pharmacokinetic Parameters of Valproic Acid

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (planned)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the blood levels of valproic acid in subjects with different body weights and to evaluate whether the pharmacokinetic parameters of this drug is altered in the obese population.

Detailed description

Many pharmacologic agents are dosed based on the weight of the patient, and studies are conducted to determine the appropriate doses of drugs for patients with different weights in order to find the safest and most effective dose for various weights. Valproic acid is a commonly used agent for the treatment of epilepsy, as well as migraine headaches and psychiatric disorders. This prospective study is designed to evaluate the effects of obesity on the pharmacokinetic parameters of valproic acid when compared to individuals at their healthy weight.

Conditions

• Healthy
• Obesity
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Valproic acid

Timeline

• Start date: 2006-03-01
• Completion: 2007-03-01
• First posted: 2006-03-03
• Last updated: 2012-07-03

Locations

1 site across 1 country: United States