Staccato® Prochlorperazine for Inhalation
Information source: Alexza Pharmaceuticals, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine
Intervention: Prochlorperazine (Drug); Prochlorperazine (Drug); Prochlorperazine (Drug); Prochlorperazine (Drug); Prochlorperazine (Drug); Prochlorperazine (Drug); Prochlorperazine (Drug); Placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Alexza Pharmaceuticals, Inc. Official(s) and/or principal investigator(s):
Daniel A Spyker, MD, Study Director, Affiliation: Alexza Pharmaceuticals, Inc.
Summary
To evaluate the tolerability and safety of inhaled prochlorperazine To evaluate the
pharmacokinetics of inhaled prochlorperazine
Clinical Details
Official title: Tolerability, Safety and Pharmacokinetics of a Single Dose of Staccato™ Prochlorperazine for Inhalation in Normal, Healthy Volunteers
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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 and Contacts
PPD Phase I Clinic, Austin, Texas 78704-7016, United States
Additional Information
Starting date: September 2005
Ending date: November 2005
Last updated: February 25, 2008
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