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.

Completed

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PharmaKinetics Laboratories, Inc

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prochlorperazine suppositories, 25mg

Drug

Compazine® suppositories, 25mg

Drug

Primary outcomes

Bioequivalence according to US FDA guidelines

Sponsors and collaborators

Lead sponsor

Padagis LLC

Industry

Registry information

Important dates

First posted: Oct 9, 2009
Registry last updated: Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed