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Pharmacokinetics Of Celecoxib Test Formulations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00925106
Recruitment Status : Completed
First Posted : June 19, 2009
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE June 18, 2009
First Posted Date  ICMJE June 19, 2009
Last Update Posted Date February 2, 2021
Study Start Date  ICMJE July 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2009)
  • AUCinf, AUCt, Cmax [ Time Frame: 1.5 month ]
  • Visual inspection of median plasma concentration versus time profiles resulting from each formulation [ Time Frame: 1.5 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2009)
  • Tmax, half-life [ Time Frame: 1.5 month ]
  • adverse events, laboratory tests, vital signs [ Time Frame: 1.5 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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
Current Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Original Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Current Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Original Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
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