Study Evaluating Inhaled AeroLEF (Liposome-Encapsulated Fentanyl)in Normal Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT00708318|
Recruitment Status : Completed
First Posted : July 2, 2008
Last Update Posted : July 2, 2008
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: i.v. fentanyl and AeroLEF||Phase 1|
In Period I, subjects received an intravenous dose of fentanyl (200 µg) administered over 1 minute (Treatment A). Subjects then crossed over to Period II.
In Period II, subjects were randomly assigned to receive either 2 mL (1000 µg fentanyl; Treatment B) or 3mL (1500 µg fentanyl; Treatment C) of AeroLEF delivered by nebulization with the AeroEclipse BAN. Subjects were instructed to continue inhalation of AeroLEF for approximately 1 minute beyond the point of nebulizer sputter to ensure that all aerosolized medication was delivered. There was at least a 1 week washout period between study periods.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot, Phase I, 2-Period, Fasting, Bioavailability, Safety and PK Study Evaluating A Single Dose Intravenous Fentanyl 200 µg) and Single Doses of 2 or 3 mL AeroLEF (Liposome-Encapsulated Fentanyl 500 µg/mL) in Normal Healthy Non Subjects|
|Study Start Date :||October 2001|
|Actual Primary Completion Date :||November 2001|
|Actual Study Completion Date :||June 2002|
|Experimental: A, B, C||
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.
- Adverse Events [ Time Frame: continuously ]
- pharmacokinetics [ Time Frame: various time points ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00708318
|University of Toronto|
|Toronto, Ontario, Canada, M1L4S4|
|Study Director:||Diana Pilura, PhD||YM BioSciences|
|Principal Investigator:||Paul Y Tam, MD, FACP||University of Toronto, Ontario, Canada|