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Staccato Zaleplon Single Dose Pharmacokinetics

NCT00620620 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-03-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Alexza Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel A Spyker, MD · Alexza Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-03-31
Completion
2008-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00620620 on ClinicalTrials.gov