A Preliminary Comparison of the Blood Levels of Medications in Obese Subjects Compared to Post-Gastric Bypass Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- AUC Post Surgery (n =5) Compared to AUC Control (n=5)
研究概览
简要总结
The purpose of this study is to determine the difference, if any, in the area under the sertraline plasma level time curve (AUC) between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for body mass index (BMI), age and gender.
详细描述
Secondary objectives include the determination of changes in mean CPmax, Time to CPmax and Volume of Distribution between the two groups. Also, assessment of subject tolerance of sertraline utilizing the UKU side effect rating scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects between the ages of 18 and 60 years.
- •Subjects must be of good general health by history and physical exam.
- •Five subjects 9 to 15 months past bariatric surgery (Roux-en-Y procedure), no BMI requirement.
- •Five subjects matched for body mass index, age and sex to the post bariatric surgery group.
- •No contraindications to receiving a single dose of 100 mg of sertraline.
- •Women of child bearing potential must be practicing an accepted method of birth control (barrier method or oral contraception) and have a negative pregnancy test at baseline.
排除标准
- •Allergy to sertraline or any of its constituents.
- •Candidates currently receiving sertraline or any other antidepressant.
- •Candidates currently receiving a medication that interacts with sertraline (Zoloft)
- •Candidates who are poor metabolizers for the CYP2D6 and/or 2C19 enzymes.
- •Candidates experiencing clinically significant, unstable neurological, hepatic, renal or cardiovascular disease.
- •Candidates currently or with a past history of meeting DSM-IV diagnostic criteria for schizophrenia, schizoaffective disorder, bipolar disorder.
- •Candidates who have participated in an investigational drug study in past 30 days.
- •Candidates who meet DSM-IV diagnostic criteria for drug/alcohol abuse or dependency or who have a history of drug/alcohol abuse or dependency.
- •Candidates who are pregnant or nursing at time of study.
研究组 & 干预措施
Post bariatric surgery
Roux en Y bariatric surgery
干预措施: bariatric surgery (Procedure)
Control
No surgery
干预措施: control (Other)
结局指标
主要结局
AUC Post Surgery (n =5) Compared to AUC Control (n=5)
时间窗: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5 hours
AUC of surgery group compared to the AUC of control group
次要结局
未报告次要终点
研究者
James Roerig
James L. Roerig, Pharm.D., BCPP, University of North Dakota Department of Clinical Neuroscience, Grand Forks, ND and the Neuropsychiatric Research Institute, Fargo, ND.
Neuropsychiatric Research Institute, Fargo, North Dakota