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This study will evaluate the drug behavior and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release formulation in 24 healthy volunteers when taken after eating a high fat meal (the effect of food). This will be compared to the drug behavior and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release formulation when taken after a 10 hour fast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tofacitinib MR 11 mg Fed | Experimental | tofacitinib modified release (MR) 11 mg tablet administered with food. |
|
| tofacitinib MR 11 mg Fasting | Experimental | tofacitinib modified release (MR) 11 mg tablet administered without food. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tofacitinib modified-release (MR) formulation | Drug | A single dose of tofacitinib modified release 11 mg tablet after receiving the standard FDA high fat/high calorie meal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from time zero to infinity | Area under the curve from time zero to infinity | 48 hours post dose |
| Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration | Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration | 48 hours post dose |
| Maximum Observed Plasma Concentration (Cmax) | Maximum Observed Plasma Concentration (Cmax) | 48 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Time to peak concentration | 48 hours post dose |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale Adventist Medical Center | Glendale | California | 91206 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| tofacitinib modified-release (MR) formulation | Drug | tofacitinib modified release (MR) 11 mg tablet after a 10 hour overnight fast. |
|
| 48 hours post dose |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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