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Staccato Zaleplon Single Dose PK

Information source: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: zaleplon (Drug); placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Alexza Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Daniel A Spyker, MD, Study Director, Affiliation: Alexza Pharmaceuticals, Inc.

Summary

The purpose of the study is to determine the safety, tolerability and pharmacokinetics of zaleplon delivered by the Staccato thermal aerosol system in healthy volunteers

Clinical Details

Official title: Safety, Tolerability, and Pharmacokinetics of a Single Dose of StaccatoŽ Zaleplon for Inhalation in Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Examine the tolerability and safety of Staccato Zaleplon in a healthy volunteer population;

Secondary outcome: Establish the plasma level-time profile (pharmacokinetics) of zaleplon in the target therapeutic range following single Staccato Zaleplon doses

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female subjects between the ages of 18 to 55 years, inclusive who are in

good general health Exclusion Criteria:

- Subjects with a history of allergy or intolerance to zaleplon. Subjects who have any

other disease or condition, by history, physical examination, or laboratory abnormalities that in the investigator's opinion, would present undue risk to the subject, or may confound the interpretation of study results.

Locations and Contacts

Covance Clinical Research Unit Inc., Evansville, Indiana 47714, United States
Additional Information

Starting date: February 2008
Last updated: July 13, 2013

Page last updated: August 23, 2015

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