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Pharmacokinetics Of Celecoxib Test Formulations

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: Celebrex capsule (Drug); Test formulation D1 (Drug); Test formulation D2 (Drug); Test formulation D3 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

AUCinf, AUCt, Cmax

Visual inspection of median plasma concentration versus time profiles resulting from each formulation

Secondary outcome:

Tmax, half-life

adverse events, laboratory tests, vital signs

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

Locations and Contacts

Pfizer Investigational Site, New Haven, Connecticut 06511-5473, United States
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: July 2009
Last updated: August 19, 2010

Page last updated: August 20, 2015

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