Healthy Volunteers
Conditions
Keywords
Bioavailability, pharmacokinetics, celecoxib
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.
Interventions
DRUGCelebrex capsule
Single dose 200 mg commercial Celebrex capsule
DRUGTest formulation D1
Single dose 150 mg celecoxib as formulation D1
DRUGTest formulation D2
Single dose 150 mg celecoxib as formulation D2
DRUGTest formulation D3
Single dose 150 mg celecoxib as formulation D3
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCinf, AUCt, Cmax | 1.5 month |
| Visual inspection of median plasma concentration versus time profiles resulting from each formulation | 1.5 month |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, half-life | 1.5 month |
| adverse events, laboratory tests, vital signs | 1.5 month |
Countries
United States
Outcome results
None listed