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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.


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


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Male.


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

Page last updated: August 23, 2015

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