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临床试验/NCT01792453
NCT01792453已完成不适用

MRI Quantification of Gastric and Small Bowel Liquid Volumes Before and After Ingestion of the Standard Oral Solid Delivery 240 mL Water Drink

University of Nottingham2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Time course of small bowel liquid volume after ingesting 240 mL of water

研究概览

简要总结

The GI MRI Research group at the University of Nottingham has been developing new, non-invasive magnetic resonance imaging (MRI) techniques to image the gastrointestinal tract. The investigators now want to characterise; in collaboration with the College of Pharmacy at the University of Michigan, the fasting volumes of gastric and small bowel liquid and their time courses over 2 hours after drinking the FDA recommended 240 mL of water drink for oral solid dosage forms testing.

详细描述

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 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Previous gastrointestinal surgery (excluding cholecystectomy and appendectomy)
  • Known gastrointestinal disease
  • 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

结局指标

主要结局

Time course of small bowel liquid volume after ingesting 240 mL of water

时间窗: 0 - 120 mins

Time course for the volume of freely mobile water in the small bowel over 2 hours

次要结局

  • Time course of gastric liquid volume after ingesting 240 mL of water(0 - 120 mins)
  • Number of liquid pockets in the small bowel(0 - 120 mins)
  • Volume of liquid pockets in the small bowel(0 - 120 mins)
  • Summary information on the location of liquid pockets by quadrant(0 - 120 mins)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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