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OpenTrials
Completed

NCT Number: NCT00925106

Pharmacokinetics Of Celecoxib Test Formulations

The pharmacokinetics of new formulations of celecoxib are being evaluated. They are expected to provide more favorable bioavailability characteristics than the present commercial formulation.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511-5473, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celebrex Capsule

Drug

Single dose 200 mg commercial Celebrex capsule

Test formulation D1

Drug

Single dose 150 mg celecoxib as formulation D1

Test formulation D2

Drug

Single dose 150 mg celecoxib as formulation D2

Test formulation D3

Drug

Single dose 150 mg celecoxib as formulation D3

Primary outcomes

  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 outcomes

  1. Tmax, half-life

    Time frame: 1.5 month

  2. adverse events, laboratory tests, vital signs

    Time frame: 1.5 month

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

A Pilot, Open-Label, Randomized, Crossover, Pharmacokinetic Study Of Enhanced Bioavailability Celecoxib Formulations D1, D2 And D3 In Healthy Volunteers

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 19, 2009
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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