Study Evaluating Inhaled AeroLEF Delivered in 4 Aerosol Delivery Devices in Healthy Volunteers
Status:
Completed
Trial end date:
2003-05-01
Target enrollment:
Participant gender:
Summary
This was an open-label, two-phase, crossover, safety, pharmacokinetic (PK), and
pharmacodynamic (PD) study in normal, healthy, non-smoking, fasting male and female subjects.
The first phase (A. Device Qualification Phase) of the study compared three aerosol devices
to a reference device to identify a nebulizer that produced a favourable, clinically
relevant, PK and PD profile of AeroLEF. The PK and PD of the test and reference devices were
compared to 200 mcg of intravenous fentanyl administered over 1 minute.
The second phase (B. Device Characterization Phase) of the study was planned to characterize
and compare the safety, PK and PD of the selected aerosol device (identified in the Device
Qualification Phase) to 300mcg of intravenous fentanyl administered over 15 minutes if a
device was chosen during the Device Qualification Phase. The data from the selected aerosol
device would be pooled from subjects in both the Device Qualification and Device
Characterization Phases of the study.