Staccato Prochlorperazine Single Dose PK Study



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 45
Updated:11/7/2018
Start Date:August 2004
End Date:October 2004

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

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

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.

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.
We found this trial at
1
site
Austin, Texas 78744
?
mi
from
Austin, TX
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