Brief Summary

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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

Primary Measures

• Bioequivalence according to US FDA guidelines
  • Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

• Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening

Exclusion Criteria

• 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.