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A Pilot Open-Label Crossover Bioavailability Study of Celecoxib in Healthy Volunteers

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00813241
Pfizer
Completed
A Pilot Open-Label Crossover Bioavailability Study of Celecoxib in Healthy Volunteers

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A Pilot Open-Label Crossover Bioavailability Study of Celecoxib in Healthy Volunteers
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.
Pharmacokinetics
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy Volunteers
  • Drug: celecoxib reference formulation
    200 mg single oral dose of celecoxib tablets
  • Drug: celecoxib test formulation A1
    150 mg single oral dose of celecoxib A1 formulation tablets
  • Drug: celecoxib test formulation B2
    150 mg single oral dose of celecoxib B2 formulation tablets
  • Drug: celecoxib test formulation C1
    150 mg single oral dose of celecoxib Cl formulation tablets
  • Active Comparator: A
    A single dose of 200 mg celecoxib capsule administered as 1 x 200 mg celecoxib capsule, (Reference Formulation)
    Intervention: Drug: celecoxib reference formulation
  • Experimental: B
    A single dose of 150 mg celecoxib administered as 1 x 150 mg tablet formulation containing granule type A1
    Intervention: Drug: celecoxib test formulation A1
  • Experimental: C
    A single dose of 150 mg celecoxib administered as 1 x 150 mg tablet containing granule type B2
    Intervention: Drug: celecoxib test formulation B2
  • Experimental: D
    A single dose of 150 mg celecoxib administered as 1 x 150 mg tablet containing granule type C1
    Intervention: Drug: celecoxib test formulation C1
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
March 2009
March 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT00813241
A3191354
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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