Staccato Zaleplon Single Dose Pharmacokinetics
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Inhaled Zaleplon 2 mgDrug: Inhaled Zaleplon 4 mgDrug: Inhaled Zaleplon 0.5 mgDrug: Inhaled Zaleplon 1 mgDrug: Inhaled placebo
- Registration Number
- NCT00620620
- Lead Sponsor
- Alexza Pharmaceuticals, Inc.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inhaled Zaleplon 2 mg Inhaled Zaleplon 2 mg Staccato Zaleplon 2 mg Inhaled Zaleplon 4 mg Inhaled Zaleplon 4 mg Staccato Zaleplon 4 mg Inhaled Zaleplon 0.5 mg Inhaled Zaleplon 0.5 mg Staccato Zaleplon 0.5 mg Inhaled Zaleplon 1 mg Inhaled Zaleplon 1 mg Staccato Zaleplon 1 mg Inhaled Placebo Inhaled placebo Staccato Placebo
- Primary Outcome Measures
Name Time Method Examine the tolerability and safety of Staccato Zaleplon in a healthy volunteer population; Single dose
- Secondary Outcome Measures
Name Time Method Establish the plasma level-time profile (pharmacokinetics) of zaleplon in the target therapeutic range following single Staccato Zaleplon doses single dose
Trial Locations
- Locations (1)
Covance Clinical Research Unit Inc.
🇺🇸Evansville, Indiana, United States