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Staccato Prochlorperazine Single Dose PK Study

NCT00610727 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-04-22

Study results available
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Summary

The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of inhaled prochlorperazine

Conditions

Interventions

DRUG

Prochlorperazine 0.5 mg IV over 5 sec

IV Prochlorperazine for bioavailability

DRUG

Inhaled prochlorperazine 0.625 mg

Inhaled Staccato Prochlorperazine 0.625 mg

DRUG

Inhaled prochlorperazine 1.25 mg

Inhaled Staccato Prochlorperazine 1.25 mg

DRUG

Inhaled prochlorperazine 2.5 mg

Inhaled Staccato Prochlorperazine 2.5 mg

DRUG

Inhaled prochlorperazine 5 mg

InhaledStaccato Prochlorperazine 5 mg

DRUG

Inhaled prochlorperazine 10 mg

InhaledStaccato Prochlorperazine 10 mg

DRUG

Inhaled placebo

Inhaled Staccato Placebo (0 mg)

DRUG

Prochlorperazine 10 mg IV over 5 sec

Prochlorperazine 10 mg IV over 5 sec for patient qualification

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Nova Pneuma 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
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2004-10-31
Completion
2004-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00610727 on ClinicalTrials.gov