This is a pharmacokinetic study designed to determine if two oral preparations of difluoromethylornithine (DFMO) are biocompatible. We will recruit 10-20 normal volunteers who will receive two single doses of DFMO given one week apart; one dose liquid and one dose tablet. Subjects will be randomly assigned to receive either the liquid or the tablet first. Blood samples will be drawn for pharmacokinetics pre-drug, 30, 60, 90 minutes, 2, 3, 4, 6, 9, 22, and 24 hours following administration. Single-dose pharmacokinetic parameters to be assessed are peak concentration, time to peak, 24 hour AUC and elimination half-life.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR003186-15
Application #
6413082
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1994-12-01
Project End
2004-11-30
Budget Start
Budget End
Support Year
15
Fiscal Year
2000
Total Cost
Indirect Cost
Name
University of Wisconsin Madison
Department
Type
DUNS #
161202122
City
Madison
State
WI
Country
United States
Zip Code
53715
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