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In this study, a 10 mg dose of tasocitinib (CP-690,550) will be given to study subjects on three separate occasions using one of three different tablet formulations (tablet versions) each time. The amount of tasocitinib (CP-690,550) available in the blood following administration of each tablet formulation will be measured and compared. The overall aim of the study is to establish that a similar amount of tasocitinib (CP-690,550) is absorbed into the blood following administration of the same dose of each different tablet formulation.
This is a pivotal bioequivalence study for tasocitinib (CP-690,550).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental |
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| Sequence 2 | Experimental |
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| Sequence 3 | Experimental |
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| Sequence 4 | Experimental |
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| Sequence 5 | Experimental |
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| Sequence 6 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A | Drug | Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet). |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters: AUCinf, AUClast and Cmax of tasocitinib (CP-690,550). | PK blood samples out to 24 hours post dose in each period |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters: Tmax, t½ of tasocitinib (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 Period 3. |
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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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| Treatment B | Drug | Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets). |
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| Treatment C | Drug | Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets). |
|
| Treatment A | Drug | Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet). |
|
| Treatment C | Drug | Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets). |
|
| Treatment B | Drug | Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets). |
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| Treatment B | Drug | Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets). |
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| Treatment C | Drug | Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets). |
|
| Treatment A | Drug | Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet). |
|
| Treatment B | Drug | Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets). |
|
| Treatment A | Drug | Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet). |
|
| Treatment C | Drug | Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets). |
|
| Treatment C | Drug | Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets). |
|
| Treatment A | Drug | Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet). |
|
| Treatment B | Drug | Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets). |
|
| Treatment C | Drug | Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets). |
|
| Treatment B | Drug | Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets). |
|
| Treatment A | Drug | Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet). |
|
| Safety: vital signs | Prior to dosing in each period and at 24 hours post last dose in Period 3. |
| 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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