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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00402350
Other study ID # AMDC-003-101
Secondary ID 8 May 2006
Status Completed
Phase Phase 1
First received November 20, 2006
Last updated March 13, 2017
Start date April 2006
Est. completion date November 2006

Study information

Verified date February 2008
Source Alexza Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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Study Design


Related Conditions & MeSH terms


Intervention

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Locations

Country Name City State
United States Duke University Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Alexza Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Macleod DB, Habib AS, Ikeda K, Spyker DA, Cassella JV, Ho KY, Gan TJ. Inhaled fentanyl aerosol in healthy volunteers: pharmacokinetics and pharmacodynamics. Anesth Analg. 2012 Nov;115(5):1071-7. doi: 10.1213/ANE.0b013e3182691898. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To establish the plasma PK profile of fentanyl following single and multiple Staccato Fentanyl doses 8 hours
Secondary To assess Staccato Fentanyl absolute bioavailability and dose proportionality 8 hours
Secondary Safety and Tolerability of Staccato Fentanyl 8 hours
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