- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00813241
A Pilot Open-Label Crossover Bioavailability Study of Celecoxib in Healthy Volunteers
January 29, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Pharmacokinetics
Study Type
Interventional
Enrollment (Actual)
16
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
-
-
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Singapore, Singapore, 188770
- Pfizer Investigational Site
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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
21 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
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: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
A single dose of 200 mg celecoxib capsule administered as 1 x 200 mg celecoxib capsule, (Reference Formulation)
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200 mg single oral dose of celecoxib tablets
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Experimental: B
A single dose of 150 mg celecoxib administered as 1 x 150 mg tablet formulation containing granule type A1
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150 mg single oral dose of celecoxib A1 formulation tablets
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Experimental: C
A single dose of 150 mg celecoxib administered as 1 x 150 mg tablet containing granule type B2
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150 mg single oral dose of celecoxib B2 formulation tablets
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Experimental: D
A single dose of 150 mg celecoxib administered as 1 x 150 mg tablet containing granule type C1
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150 mg single oral dose of celecoxib Cl formulation tablets
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PK endpoints will include Cmax, C12h, Tmax, AUCtlqc, AUCinf, and half-life (t1/2) for each formulation as data permit
Time Frame: 2 months
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2 months
|
Visual inspection of median plasma concentration versus time profiles resulting from each formulation
Time Frame: 2 months
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2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events and safety laboratory tests
Time Frame: 2 months
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2 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
December 22, 2008
First Submitted That Met QC Criteria
December 22, 2008
First Posted (Estimate)
December 23, 2008
Study Record Updates
Last Update Posted (Actual)
February 2, 2021
Last Update Submitted That Met QC Criteria
January 29, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Celecoxib
Other Study ID Numbers
- A3191354
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.
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