NCT00992472

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

First QC Date

October 7, 2009

Last Update Submit

October 13, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence according to US FDA guidelines

Study Arms (2)

Prochlorperazine suppositories, 25mg

EXPERIMENTAL
Drug: Prochlorperazine suppositories, 25mg

Compazine® suppositories, 25mg

ACTIVE COMPARATOR
Drug: Compazine® suppositories, 25mg

Interventions

Prochlorperazine suppositories, 25mgDRUG
Prochlorperazine suppositories, 25mg
Compazine® suppositories, 25mgDRUG
Compazine® suppositories, 25mg

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening

You may not qualify if:

  • Positive test results for HIV or Hepatitis B or C
  • History of allergy or sensitivity to Prochlorperazine or related drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PharmaKinetics Laboratories, Inc

Baltimore, Maryland, 21201, United States

Location

Study Officials

  • Ferguson, M.D.

    PharmaKinetics Laboratories Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 9, 2009

Last Updated

October 21, 2021

Record last verified: 2021-10

Locations

US(1)