- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Nottingham, 영국, NG7 2RD
- University of Nottingham
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 240 mL water drink
Volunteers will be asked to drink 240 mL water drink
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Time course of small bowel liquid volume after ingesting 240 mL of water
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Time course of gastric liquid volume after ingesting 240 mL of water
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Kathryn Murray, PhD, University of Nottingham
- 수석 연구원: Caroline Hoad, PhD, University of Nottingham
- 수석 연구원: Penny Gowland, PhD, University of Nottingham
- 수석 연구원: Susan Pritchard, MSc, University of Nottingham
- 수석 연구원: Martin Garnett, University of Nottingham
- 수석 연구원: Robin Spiller, FRCP, University of Nottingham
- 수석 연구원: Gregory Amidon, University of Michigan
- 수석 연구원: Gordon Amidon, University of Michigan
- 수석 연구원: Deanna Mudie, University of Michigan
- 연구 책임자: Luca Marciani, PhD, University of Nottingham
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- A10012013
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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