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: September 24, 2013
Last verified: October 2009

October 7, 2009
September 24, 2013
Not Provided
Not Provided
Bioequivalence according to US FDA guidelines [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00992472 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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
Not Provided
Not Provided

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
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00992472
1670110293
Not Provided
Not Provided
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