Pharmacokinetics Of Celecoxib Test Formulations
Study Details
Study Description
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 |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
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
Primary Outcome Measures
- AUCinf, AUCt, Cmax [1.5 month]
- Visual inspection of median plasma concentration versus time profiles resulting from each formulation [1.5 month]
Secondary Outcome Measures
- Tmax, half-life [1.5 month]
- adverse events, laboratory tests, vital signs [1.5 month]
Eligibility Criteria
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
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | 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
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A3191355