Bioavailability of Prochlorperazine Suppositories, 25 mg
Information source: Paddock Laboratories, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Prochlorperazine suppositories, 25mg (Drug); Compazine® suppositories, 25mg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Paddock Laboratories, Inc. Official(s) and/or principal investigator(s): Ferguson, M.D., Principal Investigator, Affiliation: PharmaKinetics Laboratories, Inc.
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.
Clinical Details
Official title: Bioavailability of Prochlorperazine Suppositories, 25 mg
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioequivalence according to US FDA guidelines
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Male.
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
Locations and Contacts
PharmaKinetics Laboratories, Inc, Baltimore, Maryland 21201, United States
Additional Information
Last updated: September 24, 2013
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