A Pharmacokinetic Study to Compare the Dosing of Valproic Acid in Subjects With Different Body Weights
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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.
Condition or disease
Drug: Valproic acid
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.
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Ages Eligible for Study:
21 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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