Status:
TERMINATED
A Pharmacokinetic Study to Compare the Dosing of Valproic Acid in Subjects With Different Body Weights
Lead Sponsor:
Northwell Health
Conditions:
Healthy
Obesity
Eligibility:
All Genders
21-60 years
Phase:
PHASE4
Brief 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 ...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00298857
Start Date
March 1 2006
End Date
March 1 2007
Last Update
July 3 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040