Pharmacokinetics Of Celecoxib Test Formulations

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00925106
First received: June 18, 2009
Last updated: August 19, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: Celebrex capsule
Drug: Test formulation D1
Drug: Test formulation D2
Drug: Test formulation D3
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUCinf, AUCt, Cmax [ Time Frame: 1.5 month ] [ Designated as safety issue: No ]
  • Visual inspection of median plasma concentration versus time profiles resulting from each formulation [ Time Frame: 1.5 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tmax, half-life [ Time Frame: 1.5 month ] [ Designated as safety issue: No ]
  • adverse events, laboratory tests, vital signs [ Time Frame: 1.5 month ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: July 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925106

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511-5473
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00925106     History of Changes
Other Study ID Numbers: A3191355
Study First Received: June 18, 2009
Last Updated: August 19, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Bioavailability, pharmacokinetics, celecoxib

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

ClinicalTrials.gov processed this record on September 16, 2014