The purpose of this study is to assess the safety and pharmacokinetics of Amphotericin B lipid complex when administered to healthy male volunteers as a single 1 mg intravenous bolus test dose followed sequentially by infusions of 0.1 mg/kg, 0.25 mg/kg body weigh compared to the same dosage regimens of Fungizone (registered trademark). Sixteen subjects are to be enrolled. Serum concentrations will be measured by a highly specific, sensitive and reproducible HPLC method. The sensitivity of the method is 25 ng/ml. The standard curves are linear from 25 ng/ml to 20 ug/ml. This method was developed in the CPRL.

Agency
National Institute of Health (NIH)
Institute
Clinical Center (CLC)
Type
Intramural Research (Z01)
Project #
1Z01CL005072-02
Application #
3896287
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
2
Fiscal Year
1989
Total Cost
Indirect Cost
Name
Clinical Center
Department
Type
DUNS #
City
State
Country
United States
Zip Code