Study Evaluating Inhaled AeroLEF Delivered in 4 Aerosol Delivery Devices in Healthy Volunteers

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.

Timeline

Start

2003-03

Primary completion

2003-05

Completion

2003-05

Drugs

Indications

No indication recorded.