drugset / Trial / NCT00708318

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

NCT00708318

Phase 1 Completed 6 enrolled YM BioSciences
RandomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2001-10
Primary completion
2001-11
Completion
2002-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Fentanyl Other / unclassified 200 ug Intravenous
Subject Fentanyl Other / unclassified 1000 ug Intravenous
Subject Fentanyl Other / unclassified 1500 ug Intravenous

Indications

No indication recorded.