Food and Drug Administration

Description

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.

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities / Indian housing authorities
• Native American tribal organizations (other than Federally recognized)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others

Contact

Bryce Jones <br/>Grants Management Specialist <br/>Phone 240-402-2111
bryce.jones@fda.hhs.gov