A Preliminary Comparison of the Effect of Roux-en-Y Bariatric Surgery on Blood Levels of Duloxetine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This study aims to determine the difference, if any, in the pharmacokinetics of duloxetine 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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.
- •Ten experimental subjects 9 to 15 months post bariatric surgery (Roux-en-Y procedure), no BMI requirement.
- •Ten normal control subjects who have met the inclusion criteria and have not received bariatric surgery and who are matched to the surgery subjects according to body mass index, age and sex.
- •Women of child bearing potential must be practicing an accepted method of birth control (barrier method or oral contraceptive) and have a negative pregnancy test at baseline.
- •No contraindications to receiving a single capsule of 60 mg of duloxetine
排除标准
- •Allergy to duloxetine or any of its constituents.
- •Candidates who are pregnant or nursing
- •Candidates currently receiving any antidepressant.
- •Candidates that are determined to be poor metabolizers for CYP2D6
- •Subjects who smoke or use any nicotine products
- •Candidates currently receiving a medication that interacts with duloxetine.
- •Candidates experiencing clinically significant, unstable neurological, hepatic, renal or cardiovascular disease.
- •Candidates experiencing or with a history of vomiting or diarrhea associated with bariatric surgery
- •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.
研究组 & 干预措施
Active drug
All subjects received drug. Single arm.
干预措施: Duloxetine (Drug)
结局指标
主要结局
Cmax
时间窗: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72
The difference, if any, in the pharmacokinetics parameters (Cmax) of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for BMI, age and gender.
Tmax
时间窗: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72
Time to maximum plasma concentration
AUCo-inf,
时间窗: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72
Area under the plasma concentration time curve
T1/2
时间窗: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72
Half life
次要结局
- Emesis(4 days)
研究者
James Roerig
James L Roerig, PharmD, BCPP, Neuropsychiatric Research Institute and University of North Dakota
Neuropsychiatric Research Institute, Fargo, North Dakota