DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017