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Staccato® Fentanyl Pharmacokinetics in Healthy Volunteers

2014-08-27 03:41:27 | BioPortfolio

Summary

The Phase I clinical trial in approximately 50 healthy volunteers will be conducted at a single clinical center in two stages. Stage 1 is an open-label, cross-over comparison of a single dose of Staccato Fentanyl and an equivalent dose of intravenous (IV) fentanyl. Stage 2 is a randomized, doubleblind, placebo-controlled dose escalation of Staccato Fentanyl, evaluating multiple doses of fentanyl. The three primary aims of the Phase I clinical trial are to evaluate the pharmacokinetics (PK) and absolute bioavailability for Fentanyl, compare the Staccato Fentanyl PK profile to the IV fentanyl PK profile, and examine the tolerability and safety of Staccato Fentanyl in a non-opioid-tolerant, healthy volunteer population.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatm

Conditions

Breakthrough Pain

Intervention

Staccato Fentanyl, Staccato Fentanyl, Staccato Fentanyl, Staccato Fentanyl, Staccato Fentanyl, Staccato placebo

Location

Duke University
Durham
North Carolina
United States
27710

Status

Completed

Source

Alexza Pharmaceuticals, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:41:27-0400

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Medical and Biotech [MESH] Definitions

A potent narcotic analgesic, abuse of which leads to habituation or addiction. It is primarily a mu-opioid agonist. Fentanyl is also used as an adjunct to general anesthetics, and as an anesthetic for induction and maintenance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1078)

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