A Comparison of Sustained and Extended Release Bupropion Following Bariatric Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Bupropion Plasma Concentrations/Area-Under-the-Curve (AUC)
研究概览
简要总结
This study is being conducted to evaluate how the body absorbs and processes the sustained release (SR) and extended release (XL) medication bupropion (Wellbutrin®). Subject who are 1-3 years post gastric bypass surgery will be invited to participate. Non-surgical controls will also be enrolled based on a matching criteria to post gastric bypass subjects. Participants will be asked to complete two 12-hour study days approximately 11 days apart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female
- •Age 18-65 (inclusive, at time of informed consent)
- •No tobacco use in the past three months.
- •Underwent Roux-en-Y Gastric Bypass weight loss surgery 12-36 months prior to study OR has not had a weight loss surgery but matches the gastric bypass patients on age, gender, and BMI.
- •Ability to read, write and understand English
排除标准
- •Taking a medication that has a clinically significant interaction with bupropion or an interaction that may alter the study data.
- •Hypersensitivity to bupropion or any excipient contained within the dosage forms.
- •Inability to tolerate repeated blood draws.
- •Any history of bipoloar disorder or a psychotic disorder.
- •Current major depressive disorder or current suicidality.
- •Alcohol or substance dependence in the past year.
- •Currently pregnant or lactating or unwillingness to use medically accepted contraception during study
- •Taking a medication which significantly alters gastrointesinal transit time or significantly reduces acid secretion (e.g. routine use of proton pump inhibitors, H2 antagonists, sucralfate).
- •Medical conditon which may increase participant risk with bupropion (e.g., history of significant head injury, seizure disorder, etc.)
- •Self reported history of viral hepatits or HIV.
- •Positive urine drug screen unless documented prescription of a non-interacting medication.
- •History of seizures or epilepsy or other conditions which may increase seizure risk with bupropion as described in the package insert (e.g. history of significant head injury, alcoholism, etc).
- •History of eating disorder such as anorexia nervosa or bulimia.
- •Renal impairment as evidenced by an estimated glomerular filtration rate of less than 60 ml/min/1.73 m2 as reported by the laboratory, or any other abnormality on a renal panel that the medical provider feels puts the participant at risk or may compromise the study data
- •Hepatic insufficiency as defined by any hepatic enzyme greater than 3x the upper limit of normal or other hepatic laboratory abnormalities at the discretion of the medical provider.
- •Any significant electrolyte abnormality on a basic metabolic panel that the medical provider feels may put the subject at risk of a seizure from bupropion.
研究组 & 干预措施
Bupropion
Bupropion SR and XL, single dosages of each separated by a wash-out period
干预措施: Bupropion SR and XL (Drug)
结局指标
主要结局
Bupropion Plasma Concentrations/Area-Under-the-Curve (AUC)
时间窗: 48 hours intervals
The primary aim of this research is to provide a comparison of pharmacokinetic measures associated with a single dose of bupropion SR (sustained release) and bupropion XL (extended release) in Roux-en-Y Gastric Bypass and matched nonsurgical "control" subjects. Comparisons will be based upon bupropion plasma concentrations obtained during the 48 hour sample collection window.
次要结局
- Secondary PK Characteristics(48 hour collection)
研究者
Kristine Steffen
Associate Professor
North Dakota State University