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. Identifier: NCT00925106
Recruitment Status : Completed
First Posted : June 19, 2009
Last Update Posted : August 23, 2010
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Celebrex capsule Drug: Test formulation D1 Drug: Test formulation D2 Drug: Test formulation D3 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Pilot, Open-Label, Randomized, Crossover, Pharmacokinetic Study Of Enhanced Bioavailability Celecoxib Formulations D1, D2 And D3 In Healthy Volunteers
Study Start Date : July 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Celebrex capsule
Commercial capsule
Drug: Celebrex capsule
Single dose 200 mg commercial Celebrex capsule
Experimental: D1
Test formulation D1
Drug: Test formulation D1
Single dose 150 mg celecoxib as formulation D1
Experimental: D2
Test formulation D2
Drug: Test formulation D2
Single dose 150 mg celecoxib as formulation D2
Experimental: D3
Test formulation D3
Drug: Test formulation D3
Single dose 150 mg celecoxib as formulation D3

Primary Outcome Measures :
  1. AUCinf, AUCt, Cmax [ Time Frame: 1.5 month ]
  2. Visual inspection of median plasma concentration versus time profiles resulting from each formulation [ Time Frame: 1.5 month ]

Secondary Outcome Measures :
  1. Tmax, half-life [ Time Frame: 1.5 month ]
  2. adverse events, laboratory tests, vital signs [ Time Frame: 1.5 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00925106

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511-5473
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00925106     History of Changes
Other Study ID Numbers: A3191355
First Posted: June 19, 2009    Key Record Dates
Last Update Posted: August 23, 2010
Last Verified: August 2010

Keywords provided by Pfizer:
Bioavailability, pharmacokinetics, celecoxib

Additional relevant MeSH terms:
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents