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Pharmacokinetics Of Celecoxib Test Formulations

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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. )

Study Description
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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 Design
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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

Arms and Interventions
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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


Outcome Measures
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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 ]

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

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00925106


Locations
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United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511-5473
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier: NCT00925106    
Other Study ID Numbers: A3191355
First Posted: June 19, 2009    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
Bioavailability, pharmacokinetics, celecoxib
Additional relevant MeSH terms:
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Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action