Evaluating predictive methods and product performance in Healthy Adults for Pediatric Patients, Case Study: Furosemide (U01)

Earlier exploratory CDER research projects showed that dissolution and/or solubility of a poorly soluble drug (furosemide was studied as the model drug) was higher in medium containing milk and baby formula than that in standard buffer medium. This research project will explore in vivo performance of furosemide in healthy adult volunteers following oral dosing of furosemide tablets with dosing liquids (i.e. water, milk, baby formula and Ensure Plus™ ). The administration of dosing liquids will mimic dosing and feeding conditions in pediatric patients (two years old and younger). The study will be designed with emphasis on the absorption phase and for careful characterization of the furosemide concentration-time profiles during the first 6 hours after dosing.