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Staccato Prochlorperazine Single Dose PK Study | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Staccato Prochlorperazine Single Dose PK Study

Tolerability, Safety and Pharmacokinetics of a Single Dose of Staccato™ Prochlorperazine for Inhalation in Normal, Healthy Volunteers

NCT00610727•Alexza Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

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

Detailed Description

The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of a single, inhaled dose of prochlorperazine (PCZ), administered as 1 or 2 puffs in healthy young volunteers.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects will be male or female subjects between the ages 18 to 45 years, inclusive in good general health as determined by medical history, physical examination, 12-lead ECG, spirometry, blood chemistry profile, hematology, urinalysis and in the opinion of the Principal Investigator.

Exclusion Criteria

•Subjects with a known history of allergy or intolerance to phenothiazines or related drugs or who have any disease, 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.

Locations (1)

PPD Phase I Clinic

Austin, Texas, United States

Key Dates

Start Date

August 1, 2004

Primary Completion Date

October 1, 2004

Completion Date

October 1, 2004

Last Updated

March 27, 2025

Enrollment

ACTUAL participants

Conditions

Migraine

Interventions

Prochlorperazine 0.5 mg IV over 5 sec

DRUG

Inhaled prochlorperazine 0.625 mg

DRUG

Inhaled prochlorperazine 1.25 mg

DRUG

Inhaled prochlorperazine 2.5 mg

DRUG

Inhaled prochlorperazine 5 mg

DRUG

Inhaled prochlorperazine 10 mg

DRUG

Inhaled placebo

DRUG

Prochlorperazine 10 mg IV over 5 sec

DRUG

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RECRUITINGPHASE3

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Staccato Prochlorperazine Single Dose PK Study

Inclusion Criteria

Exclusion Criteria

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Mind Body Balance for Pediatric Migraine

Light Exposure, Migraine Outcomes, and Sleep Quality

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

Prophylactic Treatment With Atorvastatin for Episodic Migraine.