HealthyPhase 1NCT00992472
Bioavailability of Prochlorperazine Suppositories, 25 mg
A Phase 1 study testing Prochlorperazine suppositories, 25mg and Compazine® suppositories, 25mg in people with Healthy, run by Padagis LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Prochlorperazine suppositories, 25mg and Compazine® suppositories, 25mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening
Who cannot join
- Positive test results for HIV or Hepatitis B or C
- History of allergy or sensitivity to Prochlorperazine or related drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
PharmaKinetics Laboratories, Inc
Baltimore, Maryland, 21201
About this study
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.
- Conditions
- Healthy
- Being tested
- Prochlorperazine suppositories, 25mg, Compazine® suppositories, 25mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prochlorperazine suppositories, 25mgDrug
Compazine® suppositories, 25mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Prochlorperazine suppositories, 25mg | Experimental | Not described Receives: Drug: Prochlorperazine suppositories, 25mg |
| Compazine® suppositories, 25mg | Active comparator | Not described Receives: Drug: Compazine® suppositories, 25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence according to US FDA guidelines
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants
Sponsor and investigators
- Lead sponsor
- Padagis LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ferguson, M.D., Principal investigator, PharmaKinetics Laboratories Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992472
- Sponsor's protocol ID
- 1670110293
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2009
- Last updated
- 21 Oct 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Prochlorperazine Suppositories, 25 mg
- ClinicalTrials.gov ID
- NCT00992472
- Acronym / sponsor ID
- 1670110293
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants
- Lead sponsor
- Padagis LLCIndustry (pharma, biotech, devices)
- First posted
- 9 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prochlorperazine suppositories, 25mg | Experimental | Drug: Prochlorperazine suppositories, 25mg |
| Compazine® suppositories, 25mg | Active comparator | Drug: Compazine® suppositories, 25mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening
Key exclusion criteria (2 listed)
- Positive test results for HIV or Hepatitis B or C
- History of allergy or sensitivity to Prochlorperazine or related drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prochlorperazine suppositories, 25mg | Drug | Prochlorperazine suppositories, 25mg |
| Compazine® suppositories, 25mg | Drug | Compazine® suppositories, 25mg |
Primary outcome
Bioequivalence according to US FDA guidelines
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ferguson, M.D. principal investigator
PharmaKinetics Laboratories Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Prochlorperazine suppositories, 25mg and Compazine® suppositories, 25mg in people with Healthy, run by Padagis LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence according to US FDA guidelines. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.