Status:
COMPLETED
Staccato Prochlorperazine Single Dose PK Study
Lead Sponsor:
Alexza Pharmaceuticals, Inc.
Collaborating Sponsors:
PPD Development, LP
Conditions:
Migraine
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00610727
Start Date
August 1 2004
End Date
October 1 2004
Last Update
March 27 2025
Active Locations (1)
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1
PPD Phase I Clinic
Austin, Texas, United States, 78704-7016