An Open-label, Prospective Trial to Determine the Effect(s) of Obesity on the Pharmacokinetic Parameters of Valproic Acid
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Area under the concentration time curve (AUC) from zero time to the 54-hour blood sampling and clearance in obese verses non-obese subjects after taking valproic acid.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Area under the concentration time curve (AUC) from zero time to the 54-hour blood sampling and clearance in obese verses non-obese subjects after taking valproic acid.
次要结局
未报告次要终点