Evaluating Predictive Methods & Product Performance in Healthy Adults for Pediatric Patients, A Case Study: Furosemide
Withdrawn before enrolling · Phase 1
Conditions studied: Medication Absorption
In brief
Poorly absorbed medications such as furosemide are common and recent experiments suggest that improvement in absorption can occur if these types of medications are consumed with liquids such as milk. The purpose of this study is to evaluate the absorption of furosemide in normal adults when taken with bottled water, milk (Parmalat™ Whole Milk), baby formula (Similac Pro-Advance™), or Ensure Plus™. These results will be used to make models that predict how these liquids will affect drug absorption in children, potentially providing ways to improve medication absorption in children.
Key facts
- Study ID
- NCT03093090
- Run by
- Yale University
- People needed
- 0
- Starts
- 2018-12-31
- Expected to finish
- 2019-06-01
- Last updated by the study team
- 2019-01-18
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age 18-40
- 4 females and 4 males will be recruited
- Free from known significant chronic medical illness (i.e., hypertension, diabetes, atherosclerosis, chronic kidney disease, liver disease, lupus, taking medications with known interactions with furosemide, a history of syncope/falls, or any acute illness, such as influenza, gastroenteritis, dehydration, electrolyte imbalance, or thrombosis risks).
- Systolic Blood Pressure ≥90 mmHg at Screening Visit
You may not qualify if…
- Inability to read English or give informed consent
- Recent hospitalization within 6 months
- Pregnant or lactating
- Allergy or intolerance to furosemide
- Allergy or intolerance to milk, milk products or soy
- Inability to return for 4 consecutive weekly overnight visits at the study site
- Female subjects with low, or borderline low blood pressure, will be evaluated carefully prior to enrollment, to ensure the safety of all subjects involved in the research study.
Where it is running
- Yale University — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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