drugset / Trial / NCT00709254

Study of Single and Multiple Doses of Inhaled AeroLEF (Liposome-Encapsulated Fentanyl)in Healthy Subjects

NCT00709254

Phase 1 Completed 12 enrolled YM BioSciences
RandomizedCrossoverOpen-labelTreatment

Summary

This study was designed to assess single-dose and multiple-dose PK and safety parameters utilizing a dosage of 3 mL (500 µg/mL)AeroLEF delivered via nebulization with the AeroEclipse BAN device. The study was conducted in opioid naïve subjects who were not blocked with naloxone or other opioid receptor antagonists.

Timeline

Start
2001-12
Primary completion
2002-01
Completion
2002-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fentanyl Other / unclassified 200 ug Intravenous
Comparator Fentanyl Other / unclassified 3 ml Intravenous

Indications

No indication recorded.