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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.
October 7, 2009
October 9, 2009
September 26, 2013
Not Provided
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Bioequivalence according to US FDA guidelines
Same as current
Complete list of historical versions of study NCT00992472 on ClinicalTrials.gov Archive Site
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Bioavailability of Prochlorperazine Suppositories, 25 mg
Bioavailability of Prochlorperazine Suppositories, 25 mg
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
  • Drug: Prochlorperazine suppositories, 25mg
  • Drug: Compazine® suppositories, 25mg
  • Experimental: Prochlorperazine suppositories, 25mg
    Intervention: Drug: Prochlorperazine suppositories, 25mg
  • Active Comparator: Compazine® suppositories, 25mg
    Intervention: Drug: Compazine® suppositories, 25mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
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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
Sexes Eligible for Study: Male
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00992472
1670110293
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Paddock Laboratories, Inc.
Not Provided
Principal Investigator: Ferguson, M.D. PharmaKinetics Laboratories Inc.
Paddock Laboratories, Inc.
October 2009

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