A Pilot Open-Label Crossover Bioavailability Study of Celecoxib in Healthy Volunteers
NCT00813241
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | A Pilot Open-Label Crossover Bioavailability Study of Celecoxib in Healthy Volunteers | |||
Official Title ICMJE | A Pilot, Open-Label, Randomized, Crossover, Pharmacokinetic Study Of Enhanced Bioavailability Formulations Of Celecoxib In Healthy Volunteers | |||
Brief Summary | A pharmacokinetic study in healthy volunteers to determine the relative bioavailability of three formulations of celecoxib to the approved formulation. | |||
Detailed Description | Pharmacokinetics | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Other | |||
Condition ICMJE | Healthy Volunteers | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 16 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | March 2009 | |||
Actual Primary Completion Date | March 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Singapore | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00813241 | |||
Other Study ID Numbers ICMJE | A3191354 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | January 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |