drugset / Trial / NCT00708318
Study Evaluating Inhaled AeroLEF (Liposome-Encapsulated Fentanyl)in Normal Healthy Subjects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.