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Bioavailability of Prochlorperazine Suppositories, 25 mg

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00992472
First Posted: October 9, 2009
Last Update Posted: September 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Paddock Laboratories, Inc.
  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
Intervention Model: Crossover Assignment
Masking: None (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

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00992472     History of Changes
Other Study ID Numbers: 1670110293
First Submitted: October 7, 2009
First Posted: October 9, 2009
Last Update Posted: September 26, 2013
Last Verified: October 2009

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