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

NCT00794209 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2008-11-19

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

i.v fentanyl, AeroLEF

* i.v fentanyl * 5 mL of AeroLEF in Opti-Mist 750E continuous flow nebulizers (Maersk Medical Inc., (USA), McAllen, Texas) * 5 mL, of AeroLEF in Misty-Neb continuous flow nebulizers (Allegiance Healthcare Corp., McGaw Park, Illinois) * 5 mL of AeroLEF in PARI LC-Plus continuous flow nebulizers (PARI Respiratory Equipment Inc., London, Ontario) * 3 mL, of AeroLEF in AeroEclipse breath-actuated nebulizers (Trudell Medical International, London, Ontario) - reference device.

Sponsors & Collaborators

  • YM BioSciences

    lead INDUSTRY

Principal Investigators

  • Edward M Sellers, MD · Ventana Clinical Research Corporation

Study Design

Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2003-05-31
Completion
2003-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00794209 on ClinicalTrials.gov