MedTrace Logo

Evaluating Predictive Methods & Product Performance in Healthy Adults for Pediatric Patients, A Case Study: Furosemide

NCT03093090 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2019-01-18

No results posted yet for this study

Summary

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.

Conditions

  • Medication Absorption

Interventions

DIETARY_SUPPLEMENT

Water

6 oz

DIETARY_SUPPLEMENT

Parmalat™ Whole Milk

6 oz

DIETARY_SUPPLEMENT

Similac Pro-Advance™

6 oz

DIETARY_SUPPLEMENT

Ensure Plus™

6 oz

DRUG

Furosemide 20 MG

Furosemide is a loop diuretic (water pill) that prevents your body from absorbing too much salt.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Jeffrey Testani, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-31
Primary Completion
2019-06-01
Completion
2019-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03093090 on ClinicalTrials.gov