Healthy VolunteersPhase 1NCT00813241
A Pilot Open-Label Crossover Bioavailability Study of Celecoxib in Healthy Volunteers
A Phase 1 study testing celecoxib reference formulation, celecoxib test formulation A1 and celecoxib test formulation B2 in people with Healthy Volunteers, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Singapore.
Trial summary
A pharmacokinetic study in healthy volunteers to determine the relative bioavailability of three formulations of celecoxib to the approved formulation. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- celecoxib reference formulation, celecoxib test formulation A1 and celecoxib test formulation B2
- 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 siteSingapore
- Study dates
- Jan 2009to Mar 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate measurement, 12-lead ECG and clinical laboratory tests);
- Body Mass Index (BMI) of approximately 18 to 32 kg/m2; and a total body weight >50 kg (110 lbs). A BMI lower limit of 17.5kg/m2 may be rounded up to 18.0 kg/m2, a BMI upper limit of 32.5 kg/m2 may be rounded down to 32.0 kg/m2 and will be acceptable for inclusion;
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial;
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing);
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen;
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor), within 6 months of screening;
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day;
- Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication;
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- 12-lead ECG demonstrating QTc >450 msec at Screening. If QTc exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility;
- Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception, as outlined in this protocol, from at least 14 days prior to the first dose of study medication until completion of follow-up procedures;
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. Depo-Provera® must be discontinued at least 6 months prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of less than or equal to 1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor;
- Use of grapefruit containing products within at least 7 days prior to the administration of study medication;
- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing;
- History of sensitivity to heparin or heparin-induced thrombocytopenia;
- Unwilling or unable to comply with the Lifestyle guidelines described in this protocol;
- Subjects who have pre-existing asthma, a known hypersensitivity to celecoxib, or have experienced asthma, urticaria or allergic-type reactions after taking sulfonamides, aspirin, selective COX-2 inhibitors, or other non-steroidal anti-inflammatory drugs (NSAIDs);
- Subjects with a prior history of ulcer disease or gastrointestinal bleeding;
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Open-Label, Randomized, Crossover, Pharmacokinetic Study Of Enhanced Bioavailability Formulations Of Celecoxib In Healthy Volunteers
A pharmacokinetic study in healthy volunteers to determine the relative bioavailability of three formulations of celecoxib to the approved formulation.
Read the detailed description
Pharmacokinetics
- Conditions
- Healthy Volunteers
- Being tested
- celecoxib reference formulation, celecoxib test formulation A1, celecoxib test formulation B2, celecoxib test formulation C1
- Keywords
- Ankylosing spondylitis,Rheumatoid Arthritis,Adenomatous Polyposis Coli,Osteoarthritis,Dysmenorrhoea,pharmacokinetic study
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxib reference formulationDrug
200 mg single oral dose of celecoxib tablets
celecoxib test formulation A1Drug
150 mg single oral dose of celecoxib A1 formulation tablets
celecoxib test formulation B2Drug
150 mg single oral dose of celecoxib B2 formulation tablets
celecoxib test formulation C1Drug
150 mg single oral dose of celecoxib Cl formulation tablets
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | A single dose of 200 mg celecoxib capsule administered as 1 x 200 mg celecoxib capsule, (Reference Formulation) Receives: Drug: celecoxib reference formulation |
| B | Experimental | A single dose of 150 mg celecoxib administered as 1 x 150 mg tablet formulation containing granule type A1 Receives: Drug: celecoxib test formulation A1 |
| C | Experimental | A single dose of 150 mg celecoxib administered as 1 x 150 mg tablet containing granule type B2 Receives: Drug: celecoxib test formulation B2 |
| D | Experimental | A single dose of 150 mg celecoxib administered as 1 x 150 mg tablet containing granule type C1 Receives: Drug: celecoxib test formulation C1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK endpoints will include Cmax, C12h, Tmax, AUCtlqc, AUCinf, and half-life (t1/2) for each formulation as data permit
Measured: 2 months
Visual inspection of median plasma concentration versus time profiles resulting from each formulation
Measured: 2 months
Secondary outcomes (1)
Adverse events and safety laboratory tests
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionMar 2009
- Study completionMar 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
- Other
- 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
- NCT00813241
- Sponsor's protocol ID
- A3191354
- Status last verified
- Jan 2021
- First submitted
- 22 Dec 2008
- 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 Formulations Of Celecoxib In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00813241
- Acronym / sponsor ID
- A3191354
- Conditions
- Healthy Volunteers
- Keywords
- Ankylosing spondylitis,Rheumatoid Arthritis,Adenomatous Polyposis Coli,Osteoarthritis,Dysmenorrhoea,pharmacokinetic study
- 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
- Jan 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 23 Dec 2008 (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.
A pharmacokinetic study in healthy volunteers to determine the relative bioavailability of three formulations of celecoxib to the approved formulation.
Detailed description
Pharmacokinetics
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: celecoxib reference formulationA single dose of 200 mg celecoxib capsule administered as 1 x 200 mg celecoxib capsule, (Reference Formulation) |
| B | Experimental | Drug: celecoxib test formulation A1A single dose of 150 mg celecoxib administered as 1 x 150 mg tablet formulation containing granule type A1 |
| C | Experimental | Drug: celecoxib test formulation B2A single dose of 150 mg celecoxib administered as 1 x 150 mg tablet containing granule type B2 |
| D | Experimental | Drug: celecoxib test formulation C1A single dose of 150 mg celecoxib administered as 1 x 150 mg tablet containing granule type C1 |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate measurement, 12-lead ECG and clinical laboratory tests);
- Body Mass Index (BMI) of approximately 18 to 32 kg/m2; and a total body weight >50 kg (110 lbs). A BMI lower limit of 17.5kg/m2 may be rounded up to 18.0 kg/m2, a BMI upper limit of 32.5 kg/m2 may be rounded down to 32.0 kg/m2 and will be acceptable for inclusion;
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial;
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Key exclusion criteria (16 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing);
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen;
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor), within 6 months of screening;
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day;
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 |
|---|---|---|
| celecoxib reference formulation200 mg single oral dose of celecoxib tablets | Drug | A |
| celecoxib test formulation A1150 mg single oral dose of celecoxib A1 formulation tablets | Drug | B |
| celecoxib test formulation B2150 mg single oral dose of celecoxib B2 formulation tablets | Drug | C |
| celecoxib test formulation C1150 mg single oral dose of celecoxib Cl formulation tablets | Drug | D |
Primary outcome
PK endpoints will include Cmax, C12h, Tmax, AUCtlqc, AUCinf, and half-life (t1/2) for each formulation as data permit
Time frame: 2 months
Visual inspection of median plasma concentration versus time profiles resulting from each formulation
Time frame: 2 months
1 secondary outcome
Adverse events and safety laboratory tests
Time frame: 2 months
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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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 celecoxib reference formulation, celecoxib test formulation A1 and celecoxib test formulation B2 in people with Healthy Volunteers, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Singapore.
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 4 inclusion and 16 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 Singapore. 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?
PK endpoints will include Cmax, C12h, Tmax, AUCtlqc, AUCinf, and half-life (t1/2) for each formulation as data permit (time frame: 2 months). 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.