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Bioavailability of Prochlorperazine Suppositories, 25 mg

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.
 
ClinicalTrials.gov Identifier: NCT00992472
Recruitment Status : Completed
First Posted : October 9, 2009
Last Update Posted : October 21, 2021
Sponsor:
Information provided by (Responsible Party):
Padagis LLC

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: Prochlorperazine suppositories, 25mg Drug: Compazine® suppositories, 25mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 42 participants
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 the National Library of Medicine


Arm Intervention/treatment
Experimental: Prochlorperazine suppositories, 25mg Drug: Prochlorperazine suppositories, 25mg
Active Comparator: Compazine® suppositories, 25mg Drug: Compazine® suppositories, 25mg



Primary Outcome Measures :
  1. Bioequivalence according to US FDA guidelines


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

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
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United States, Maryland
PharmaKinetics Laboratories, Inc
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Padagis LLC
Investigators
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Principal Investigator: Ferguson, M.D. PharmaKinetics Laboratories Inc.
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Responsible Party: Padagis LLC
ClinicalTrials.gov Identifier: NCT00992472    
Other Study ID Numbers: 1670110293
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 2021
Additional relevant MeSH terms:
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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