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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

Tracking Information
First Submitted Date  ICMJE October 7, 2009
First Posted Date  ICMJE October 9, 2009
Last Update Posted Date October 21, 2021
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2009)
Bioequivalence according to US FDA guidelines
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability of Prochlorperazine Suppositories, 25 mg
Official Title  ICMJE Bioavailability of Prochlorperazine Suppositories, 25 mg
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Prochlorperazine suppositories, 25mg
  • Drug: Compazine® suppositories, 25mg
Study Arms  ICMJE
  • Experimental: Prochlorperazine suppositories, 25mg
    Intervention: Drug: Prochlorperazine suppositories, 25mg
  • Active Comparator: Compazine® suppositories, 25mg
    Intervention: Drug: Compazine® suppositories, 25mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 8, 2009)
42
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00992472
Other Study ID Numbers  ICMJE 1670110293
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Padagis LLC
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Padagis LLC
Original Study Sponsor  ICMJE Paddock Laboratories, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ferguson, M.D. PharmaKinetics Laboratories Inc.
PRS Account Padagis LLC
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP