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

• Status: Terminated
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Northwell Health
• Treatments: Valproic Acid

Criteria

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