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TERMINATEDPhase 4NCT00298857

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

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 ...

Lead sponsor: Northwell Health•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Northwell Health

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.

Age

21 - 60 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male or Female age 21-60 years
•Normal healthy volunteers as per interview at screening
•Willing and able to provide written informed consent and comply with the study protocol

Exclusion Criteria

•Inability to take oral medications
•pregnant or lactating females
•known hypersensitivity to valproic acid
•BMI less than 18.5 kg/m\^2
•BMI between 25 and 29.9 kg/m\^2, inclusive
•Taking any drug or dietary supplement within one week prior to study period
•Consumption of food 6 hours prior to study drug ingestion
•Know family history or history of urea cycle disorders
•Past history of pancreatitis
•Past history of liver disease

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 3, 2012Terms

Trial snapshot

StatusTERMINATED

PhasePHASE4

Enrollment22

Start dateMar 2006

Last updatedJul 3, 2012

Condition

Healthy Obesity Pharmacokinetics

Locations shown

Long Island Jewish Medical Center

New Hyde Park, New York

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2012Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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