Healthy VolunteersPhase 1NCT00925106
Pharmacokinetics Of Celecoxib Test Formulations
A Phase 1 study testing Celebrex capsule, Test formulation D1 and Test formulation D2 in people with Healthy Volunteers, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in United States.
Trial summary
The pharmacokinetics of new formulations of celecoxib are being evaluated. They are expected to provide more favorable bioavailability characteristics than the present commercial formulation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Celebrex capsule, Test formulation D1 and Test formulation D2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Aug 2009
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female volunteers
- Body weight BMI 17.5-30.5
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
- Positive urine drug screen
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511-5473
About this study
Official title: A Pilot, Open-Label, Randomized, Crossover, Pharmacokinetic Study Of Enhanced Bioavailability Celecoxib Formulations D1, D2 And D3 In Healthy Volunteers
The pharmacokinetics of new formulations of celecoxib are being evaluated. They are expected to provide more favorable bioavailability characteristics than the present commercial formulation.
- Conditions
- Healthy Volunteers
- Being tested
- Celebrex capsule, Test formulation D1, Test formulation D2, Test formulation D3
- Keywords
- Bioavailability, pharmacokinetics, celecoxib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celebrex capsuleDrug
Single dose 200 mg commercial Celebrex capsule
Test formulation D1Drug
Single dose 150 mg celecoxib as formulation D1
Test formulation D2Drug
Single dose 150 mg celecoxib as formulation D2
Test formulation D3Drug
Single dose 150 mg celecoxib as formulation D3
| Study group | Role | What they receive |
|---|---|---|
| Celebrex capsule | Active comparator | Commercial capsule Receives: Drug: Celebrex capsule |
| D1 | Experimental | Test formulation D1 Receives: Drug: Test formulation D1 |
| D2 | Experimental | Test formulation D2 Receives: Drug: Test formulation D2 |
| D3 | Experimental | Test formulation D3 Receives: Drug: Test formulation D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf, AUCt, Cmax
Measured: 1.5 month
Visual inspection of median plasma concentration versus time profiles resulting from each formulation
Measured: 1.5 month
Secondary outcomes (2)
Tmax, half-life
Measured: 1.5 month
adverse events, laboratory tests, vital signs
Measured: 1.5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925106
- Sponsor's protocol ID
- A3191355
- Status last verified
- Jan 2021
- First submitted
- 18 Jun 2009
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Open-Label, Randomized, Crossover, Pharmacokinetic Study Of Enhanced Bioavailability Celecoxib Formulations D1, D2 And D3 In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00925106
- Acronym / sponsor ID
- A3191355
- Conditions
- Healthy Volunteers
- Keywords
- Bioavailability, pharmacokinetics, celecoxib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 19 Jun 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 pharmacokinetics of new formulations of celecoxib are being evaluated. They are expected to provide more favorable bioavailability characteristics than the present commercial formulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Celebrex capsule | Active comparator | Drug: Celebrex capsuleCommercial capsule |
| D1 | Experimental | Drug: Test formulation D1Test formulation D1 |
| D2 | Experimental | Drug: Test formulation D2Test formulation D2 |
| D3 | Experimental | Drug: Test formulation D3Test formulation D3 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male or female volunteers
- Body weight BMI 17.5-30.5
Key exclusion criteria (2 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
- Positive urine drug screen
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 |
|---|---|---|
| Celebrex capsuleSingle dose 200 mg commercial Celebrex capsule | Drug | Celebrex capsule |
| Test formulation D1Single dose 150 mg celecoxib as formulation D1 | Drug | D1 |
| Test formulation D2Single dose 150 mg celecoxib as formulation D2 | Drug | D2 |
| Test formulation D3Single dose 150 mg celecoxib as formulation D3 | Drug | D3 |
Primary outcome
AUCinf, AUCt, Cmax
Time frame: 1.5 month
Visual inspection of median plasma concentration versus time profiles resulting from each formulation
Time frame: 1.5 month
2 secondary outcomes
Tmax, half-life
Time frame: 1.5 month
adverse events, laboratory tests, vital signs
Time frame: 1.5 month
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 2 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Screening Protocol
Pain
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.
Pfizer CT.gov Call Center study director
Pfizer
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 Celebrex capsule, Test formulation D1 and Test formulation D2 in people with Healthy Volunteers, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. 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 2 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 2 Feb 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?
AUCinf, AUCt, Cmax (time frame: 1.5 month). The study lists 2 primary outcomes in all. 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 2 Feb 2021.