- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00992472
Bioavailability of Prochlorperazine Suppositories, 25 mg
October 13, 2021 updated by: Padagis LLC
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
42
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- PharmaKinetics Laboratories, Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Prochlorperazine suppositories, 25mg
|
|
ACTIVE_COMPARATOR: Compazine® suppositories, 25mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Bioequivalence according to US FDA guidelines
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ferguson, M.D., PharmaKinetics Laboratories Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
October 7, 2009
First Submitted That Met QC Criteria
October 8, 2009
First Posted (ESTIMATE)
October 9, 2009
Study Record Updates
Last Update Posted (ACTUAL)
October 21, 2021
Last Update Submitted That Met QC Criteria
October 13, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Dopamine Agents
- Dopamine Antagonists
- Prochlorperazine
Other Study ID Numbers
- 1670110293
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on Prochlorperazine suppositories, 25mg
-
Alexza Pharmaceuticals, Inc.PPDCompleted
-
Peking University Shenzhen HospitalBGI, ChinaRecruiting
-
Sihuan Pharmaceutical Holdings Group Ltd.Unknown
-
Idorsia Pharmaceuticals Ltd.Janssen Biotech, Inc.Completed
-
Engelhard Arzneimittel GmbH & Co.KGUnknownSymptoms of Acute Bronchitis Accompanied by CoughingGermany
-
Wake Forest University Health SciencesNot yet recruiting
-
Kristina A. ButlerCompletedVaginal SurgeryUnited States
-
AstraZenecaCompleted
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.UnknownDiabetic Peripheral Neuropathy
-
Percheron TherapeuticsRecruitingDuchenne Muscular DystrophyTurkey, United Kingdom, Australia, Serbia, Bulgaria