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Pharmacokinetics of Staccato Zaleplon

This study has been completed.
Sponsor:
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00620620
First received: February 7, 2008
Last updated: July 4, 2008
Last verified: July 2008
History of Changes

February 7, 2008
July 4, 2008
February 2008
March 2008   (final data collection date for primary outcome measure)
Examine the tolerability and safety of Staccato Zaleplon in a healthy volunteer population; [ Time Frame: Single dose ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00620620 on ClinicalTrials.gov Archive Site
Establish the plasma level-time profile (pharmacokinetics) of zaleplon in the target therapeutic range following single Staccato Zaleplon doses [ Time Frame: single dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetics of Staccato Zaleplon
Safety, Tolerability, and Pharmacokinetics of a Single Dose of Staccato® Zaleplon for Inhalation in Healthy Volunteers

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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy
  • Drug: zaleplon
    Staccato Zaleplon
    Other Name: Staccato Zaleplon for Inhalation
  • Drug: placebo
    Staccato Placebo
    Other Name: Staccato Placebo for Inhalation
  • Active Comparator: 1
    Dose 1
    Interventions:
    • Drug: zaleplon
    • Drug: placebo
  • Active Comparator: 2
    Dose 2
    Interventions:
    • Drug: zaleplon
    • Drug: placebo
  • Active Comparator: 3
    Dose 3
    Interventions:
    • Drug: zaleplon
    • Drug: placebo
  • Active Comparator: 4
    Dose 4
    Interventions:
    • Drug: zaleplon
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2008
March 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00620620
AMDC-007-101, 17 December 2007
No
Robert S. Fishman, MD, FCCP; Vice President, Medical Affairs, Alexza Pharmaceuticals, Inc
Alexza Pharmaceuticals, Inc.
Not Provided
Study Director: Daniel A Spyker, MD Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals, Inc.
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP