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Study Evaluating Inhaled AeroLEF (Liposome-Encapsulated Fentanyl)in Normal Healthy Subjects

NCT00708318 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2008-07-02

No results posted yet for this study

Summary

This was a pilot, phase I, two-period, fasting, bioavailability, safety,and pharmacokinetic study evaluating single dose of i.v. fentanyl (200 µg) and single doses of 2 mL or 3 mL inhaled AeroLEF (500 µg/mL) delivered by nebulization with the AeroEclipse BAN device administered in normal healthy non-smoking subjects.

Conditions

  • Healthy

Interventions

DRUG

i.v. fentanyl and AeroLEF

Period I: subjects received an intravenous dose of fentanyl (200 µg) (Treatment A). Period II: subjects were randomly assigned to receive either 2 mL (Treatment B) or 3mL (Treatment C) of AeroLEF delivered by nebulization with an AeroEclipse BAN.

Sponsors & Collaborators

  • YM BioSciences

    lead INDUSTRY

Principal Investigators

  • Diana Pilura, PhD · YM BioSciences

  • Paul Y Tam, MD, FACP · University of Toronto, Ontario, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2001-11-30
Completion
2002-06-30

Countries

  • Canada

Study Locations

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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 NCT00708318 on ClinicalTrials.gov