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This study will explore the drug behavior and safety following a single dose of three different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in an immediate-release formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | tofacitinib (CP-690,550) modified-release formulation A-Fed |
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| Treatment B | Experimental | tofacitinib (CP-690,550) modified-release formulation B1-Fed |
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| Treatment C | Experimental | tofacitinib (CP-690,550) modified-release formulation A-Fasted |
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| Treatment D | Experimental | tofacitinib (CP-690,550) modified-release formulation B1-Fasted |
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| Treatment E | Experimental | tofacitinib (CP-690,550) modified-release formulation B2-Fasted |
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| Treatment F | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tofacitinib (CP-690,550) modified-release formulation A | Drug | A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered with food. |
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| Measure | Description | Time Frame |
|---|---|---|
| AUCinf: Area under the plasma concentration-time profile from time 0 exprapolated to infinite time | 72 hours post dose | |
| AUClast: Area under the plasma concentration-time profile from time 0 to the last with quantifiable concentration | 72 hours post dose | |
| Cmax: Maximum plasma concentration of tofacitinib (CP-690,550) | 72 hours post dose | |
| Tmax: Amount of time tofacitinib (CP-690,550) is at maximum plasma concentration | 72 hours post dose | |
| t1/2: The time required for one half of the total amount of tofacitinib (CP-690,550) to be removed from the plasma | 72 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Frel: Relative bioavailability (Frel) of tofacitinib (CP-690,550) in the modified-release formulations compared to the immediate release formulation | 24 hours post dose |
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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 Investigational Site | Singapore | 188770 | Singapore |
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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 (CP-690,550) immediate-release formulation-Fasted |
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| tofacitinib (CP-690,550) modified-release formulation B1 | Drug | A single dose of 22 mg tofacitinib (CP-690,550) MR-B1 formulation administered with food |
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| tofacitinib (CP-690,550) modified-release formulation A | Drug | A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered without food |
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| tofacitinib (CP-690,550) modified-release formulation B1 | Drug | A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B1 administered without food |
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| tofacitinib (CP-690,550) modified-release formulation B2 | Drug | A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B2 administered without food |
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| tofacitinib (CP-690,550) immediate-release formulation | Drug | A single dose of 10 mg tofacitinib (CP-690,550) immediate-release formulation administered without food |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
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