Pharmacokinetics of Staccato Zaleplon
Information source: Alexza Pharmaceuticals, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
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 Staccato® Zaleplon for Inhalation in Healthy Volunteers
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacokinetics Study
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
Ending date: April 2008
Last updated: April 9, 2008
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