NCT00620620

Staccato Zaleplon Single Dose Pharmacokinetics

Safety, Tolerability, and Pharmacokinetics of a Single Dose of Staccato® Zaleplon for Inhalation in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Inhaled placebo	Inhaled Staccato Placebo
DRUG	Inhaled Zaleplon 0.5 mg	Inhaled Staccato Zaleplon 0.5 mg
DRUG	Inhaled Zaleplon 1 mg	Inhaled Staccato Zaleplon 1 mg
DRUG	Inhaled Zaleplon 2 mg	Inhaled Staccato Zaleplon 2 mg
DRUG	Inhaled Zaleplon 4 mg	Inhaled Staccato Zaleplon 4 mg

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2008-02-21
• Last updated: 2017-03-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study