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This study will explore the drug behavior and safety following single doses of tofacitinib modified-release (MR) 11 mg and MR 22 mg in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Treatment A | Experimental | A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state. |
|
| Experimental Treatment B | Experimental | A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tofacitinib modified-release (MR) formulation | Drug | A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf(dn): Area Under the Curve From Time Zero to Infinity, dose-normalized | 72 hours post dose | |
| Cmax(dn): Maximum Observed Plasma Concentration (Cmax), dose normalized | 72 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast(dn): Area Under the Curve From Time Zero to Last Quantifiable Concentration, dose normalized | 72 hours post dose | |
| AUCinf: Area Under the Curve From Time Zero to Infinity | 72 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 | 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 modified-release (MR) formulation | Drug | A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state. |
|
| Cmax: Maximum Observed Plasma Concentration | 72 hours post dose |
| AUClast: Area Under the Curve From Time Zero to Last Quantifiable Concentration | 72 hours post dose |
| Tmax: Amount of time drug takes to reach Cmax | 72 hours post dose |
| t ½: Terminal elimination half-life | 72 hours post dose |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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