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Bioavailability of Prochlorperazine Suppositories, 25 mg

This study has been completed.
Sponsor:
Information provided by:
Paddock Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00992472
First received: October 7, 2009
Last updated: October 8, 2009
Last verified: October 2009
History of Changes
  Purpose

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
Healthy
 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:

U.S. FDA Resources

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992472

Locations
United States, Maryland
PharmaKinetics Laboratories, Inc
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Paddock Laboratories, Inc.
Investigators
Principal Investigator: Ferguson, M.D. PharmaKinetics Laboratories, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00992472     History of Changes
Other Study ID Numbers: 1670110293
Study First Received: October 7, 2009
Last Updated: October 8, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prochlorperazine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013