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Pharmacokinetics Of Celecoxib Test Formulations

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511-5473 United States
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
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male or female volunteers

- Body weight BMI 17.5-30.5

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

- Positive urine drug screen

NCT00925106
Pfizer
Completed
Pharmacokinetics Of Celecoxib Test Formulations

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Pharmacokinetics Of Celecoxib Test Formulations
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: Celebrex capsule
    Single dose 200 mg commercial Celebrex capsule
  • Drug: Test formulation D1
    Single dose 150 mg celecoxib as formulation D1
  • Drug: Test formulation D2
    Single dose 150 mg celecoxib as formulation D2
  • Drug: Test formulation D3
    Single dose 150 mg celecoxib as formulation D3
  • Active Comparator: Celebrex capsule
    Commercial capsule
    Intervention: Drug: Celebrex capsule
  • Experimental: D1
    Test formulation D1
    Intervention: Drug: Test formulation D1
  • Experimental: D2
    Test formulation D2
    Intervention: Drug: Test formulation D2
  • Experimental: D3
    Test formulation D3
    Intervention: Drug: Test formulation D3
Not Provided


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

Inclusion Criteria:

  • Healthy male or female volunteers
  • Body weight BMI 17.5-30.5

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
  • Positive urine drug screen
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00925106
A3191355
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2010

ICMJE     Data element required by the

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

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