Bioavailability of Prochlorperazine Suppositories, 25 mg

This study has been completed.
Information provided by:
Paddock Laboratories, Inc. Identifier:
First received: October 7, 2009
Last updated: September 24, 2013
Last verified: October 2009
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.

Condition Intervention Phase
Drug: Prochlorperazine suppositories, 25mg
Drug: Compazine® suppositories, 25mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bioavailability of Prochlorperazine Suppositories, 25 mg

Resource links provided by NLM:

Further study details as provided by Paddock Laboratories, Inc.:

Primary Outcome Measures:
  • Bioequivalence according to US FDA guidelines [ Designated as safety issue: No ]

Estimated Enrollment: 42
Arms Assigned Interventions
Experimental: Prochlorperazine suppositories, 25mg Drug: Prochlorperazine suppositories, 25mg
Active Comparator: Compazine® suppositories, 25mg Drug: Compazine® suppositories, 25mg


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00992472

United States, Maryland
PharmaKinetics Laboratories, Inc
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Paddock Laboratories, Inc.
Principal Investigator: Ferguson, M.D. PharmaKinetics Laboratories Inc.
  More Information Identifier: NCT00992472     History of Changes
Other Study ID Numbers: 1670110293 
Study First Received: October 7, 2009
Last Updated: September 24, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Antipsychotic Agents
Autonomic Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Tranquilizing Agents processed this record on May 23, 2016