Official Title: "Bioavailability of Prochlorperazine Suppositories, 25 mg"
The purpose of this study is to compare prochlorperazine plasma concentrations produced after administration of the test formulation with those produced after administration of a marketed reference product.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Interventions Used in this Clinical Trial
- Drug: Prochlorperazine suppositories, 25mg
- Drug: Compazine® suppositories, 25mg
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Prochlorperazine suppositories, 25mg
- Active Comparator: Compazine® suppositories, 25mg
Outcome Measures for this Clinical Trial
- Bioequivalence according to US FDA guidelines
- Safety Issue?: No
Criteria for Participation in this Clinical Trial
- Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening
- Positive test results for HIV or Hepatitis B or C
- History of allergy or sensitivity to Prochlorperazine or related drugs
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 50 Years
Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers
Clinical Trial Investigator Information
- Lead Sponsor
- Paddock Laboratories, Inc.
- Overall Official(s)
- Ferguson, M.D., Principal Investigator, PharmaKinetics Laboratories, Inc.