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Pharmacokinetic and Deposition Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet®) in Lung Transplant Recipients (Radiotagging Protocol)
The purpose of this study is to quantify the dose of aerosol medication deposited in the lungs of lung transplant recipients receiving a single nebulized treatment of aerosolized Abelcet® (lipid complexed amphotericin-B). This study is being performed to determine the range of deposited doses and patterns of distribution that could be expected in this population so that the ultimate efficacy of this preparation can be evaluated. A radioisotope technique will be utilized to track the medication dose. The study will include 12 subjects who will perform one testing session lasting approximately 3 hours. An Investigational New Drug Application (IND) detailing this protocol has been submitted by the principal investigator (PI) and approved by the Food and Drug Administration \[FDA\] (72,521).
Details
| Lead sponsor | University of Pittsburgh |
|---|---|
| Phase | Phase 3 |
| Status | TERMINATED |
| Enrolment | 12 |
| Start date | 2005-10 |
| Completion | 2006-04 |
Conditions
- Lung Transplantation
- Lung Diseases
Interventions
- Amphotericin B
Primary outcomes
- to determine the dose of medication deposited in the lungs
Countries
United States