240 mL Water Drink Study
MRI Quantification of Gastric and Small Bowel Liquid Volumes Before and After Ingestion of the Standard Oral Solid Delivery 240 mL Water Drink
研究概览
详细说明
Solid oral delivery is the most frequently used route of administration for pharmaceutical drug products. Along with other important physiological parameters, the volume of liquid in the small intestine (SILV) has the potential to greatly influence the rate and extent of drug dissolution and absorption in the GI tract, or "oral bioperformance". Modeled small bowel absorption of a drug can vary by more than five-fold as SILV decreases from 500 to 50 ml. To obtain reasonable predictions of oral bioperformance scientists must design meaningful in vitro dissolution tests and mechanistic drug transport models that capture the range of SILV in humans. However, little is known about liquid volumes in the gut, mostly due to invasiveness of previous techniques. A recent study has drawn great attention to the possibility of the liquid in the small intestine existing in discrete liquid "pockets" hence it would also be desirable to monitor the time courses and volumes of individual water pockets in the small intestine.
Magnetic resonance imaging (MRI) is the ideal tool to carry out serial and non-invasive imaging of gastrointestinal function. MRI is inherently suited to image liquid materials and this ability has been exploited to image liquids in the undisturbed gastrointestinal tract. Gastric emptying measurements have been long established and validated. Small bowel liquid volumes measurements have been recently validated against naso-duodenal infusion. Ultimately, the findings with this study will provide novel insights on the volume and distribution of ingested liquids in the gastrointestinal tract.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Nottingham、英国、NG7 2RD
- University of Nottingham
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Apparently healthy; no medical conditions that might affect the study measurements
- Male or female
- Age between 18 and 55 years of age
- Body mass index (BMI) between 18.5 and 24.9 kg m-2
- Suitable for MRI scanning (eg absence of metal implants, infusion pumps and pacemakers as assessed by the MRI safety questionnaire
Exclusion Criteria:
- Previous gastrointestinal surgery (excluding cholecystectomy and appendectomy)
- Known gastrointestinal disease
- Smoking
- History of alcohol or drug abuse
- Taking medication that is likely to affect gastrointestinal function
- Participation in night shift work the week prior to the study day. (Night work is defined as working between midnight and 6 am)
- Strenuous exercise greater than 10 hours per week
- Consumption of more than 21 units of alcohol in a typical week
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:240 mL water drink
Volunteers will be asked to drink 240 mL water drink
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Time course of small bowel liquid volume after ingesting 240 mL of water
大体时间:0 - 120 mins
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Time course for the volume of freely mobile water in the small bowel over 2 hours
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0 - 120 mins
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Time course of gastric liquid volume after ingesting 240 mL of water
大体时间:0 - 120 mins
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Gastric volumes obtained from MRI as a function of time
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0 - 120 mins
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Number of liquid pockets in the small bowel
大体时间:0 - 120 mins
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Assessment of the number of pockets of liquid in the small bowel as seen on the MR images
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0 - 120 mins
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Volume of liquid pockets in the small bowel
大体时间:0 - 120 mins
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The volume of freely mobile liquid in each of the liquid pockets identified on the MR image
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0 - 120 mins
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Summary information on the location of liquid pockets by quadrant
大体时间:0 - 120 mins
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Details on the distribution of the liquid pockets as seen on the MR images
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0 - 120 mins
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合作者和调查者
调查人员
- 首席研究员:Kathryn Murray, PhD、University of Nottingham
- 首席研究员:Caroline Hoad, PhD、University of Nottingham
- 首席研究员:Penny Gowland, PhD、University of Nottingham
- 首席研究员:Susan Pritchard, MSc、University of Nottingham
- 首席研究员:Martin Garnett、University of Nottingham
- 首席研究员:Robin Spiller, FRCP、University of Nottingham
- 首席研究员:Gregory Amidon、University of Michigan
- 首席研究员:Gordon Amidon、University of Michigan
- 首席研究员:Deanna Mudie、University of Michigan
- 研究主任:Luca Marciani, PhD、University of Nottingham
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- A10012013
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Spring water的临床试验
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Robert Bosch Gesellschaft für Medizinische Forschung...Berufsgenossenschaftliche Unfallklinik Ludwigshafen; Deutsche Gesetzliche Unfallversicherung... 和其他合作者完全的