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In this study, a 5 mg dose of CP-690,550 will be given to study subjects on two separate occasions using one of two different strength tablets each time. The amount of CP-690,550 available in the blood following administration of each tablet will be measured and compared. The overall aim of the study is to establish that a similar amount of CP-690,550 is absorbed into the blood following administration of the same dose of each different strength tablet .
This is a bioequivalence study for CP-690,550.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental |
| |
| Sequence 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A | Drug | Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets) |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters: AUCinf, AUClast and Cmax of CP-690,550 | PK blood samples out to 24 hours post dose in each period |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters: Tmax, AUCt and half-life of CP-690,550 | Derived from PK blood samples out to 24 hours post dose in each period | |
| Safety: laboratory tests | Pre-dose on Day 0 for Period 1 and at 24 hours post last dose in each period |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Personal or family history of hereditary immunodeficiency (eg, severe - Evidence of any clinically significant illness, medical condition, or disease.
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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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| Treatment B | Drug | Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet) |
|
| Treatment B | Drug | Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet) |
|
| Treatment A | Drug | Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets) |
|
| Safety: vital signs | Prior to dosing in each period and at 24 hours post last dose in Period 2 |
| Safety: adverse event reporting | Throughout study |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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