Bioavailability of Prochlorperazine Suppositories, 25 mg

Padagis LLC42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Prochlorperazine suppositories, 25mgDRUG

Compazine® suppositories, 25mgDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

PharmaKinetics Laboratories, Inc

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Bioequivalence according to US FDA guidelines

Data from ClinicalTrials.gov

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