NCT01792453

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Nottingham · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Spring water

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-03-01
• Completion: 2013-05-01
• First posted: 2013-02-15
• Last updated: 2013-07-04

Locations

1 site across 1 country: United Kingdom