Pharmacokinetics Of Celecoxib Test Formulations

NCT00925106

Last updated date
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511-5473, United States
Contact
1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Pharmacokinetics Of Celecoxib Test Formulations
Official Title  ICMJE A Pilot, Open-Label, Randomized, Crossover, Pharmacokinetic Study Of Enhanced Bioavailability Celecoxib Formulations D1, D2 And D3 In Healthy Volunteers
Brief Summary The pharmacokinetics of new formulations of celecoxib are being evaluated. They are expected to provide more favorable bioavailability characteristics than the present commercial formulation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
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
 (submitted: June 18, 2009)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00925106
Other Study ID Numbers  ICMJE A3191355
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP