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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005056-26 | EudraCT Number |
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This study will evaluate the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation in 18 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 22 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 22 mg Fed | Experimental | Single dose of tofacitinib MR 22 mg administered under fed conditions |
|
| Tofacitinib MR 22 mg Fasted | Experimental | Single dose of tofacitinib MR 22 mg administered under fasted conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib MR 22 mg (Fed) | Drug | A single dose of tofacitinib modified release 22 mg tablet after receiving the standard FDA high-fat/high-calorie meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC inf | Area under the plasma concentration-time profile from time zero to infinity (AUCinf). | 48 hours post dose |
| AUC last | Area under the plasma concentration-time profile from time zero to time of last identifiable quantitation (AUC last). | 48 hours post dose |
| Cmax | Maximum observed plasma concentration (Cmax). | 48 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 48 hours post dose | |
| Plasma Decay Half-Life (t 1/2) | 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 |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit | Brussels | B-1070 | Belgium |
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| Tofacitinib MR 22 mg (Fasted) | Drug | A single dose of tofacitinib modified release 22 mg tablet after an overnight fast of 10 hours |
|
| 48 hours post dose |