A Phase 1 interventional study of Treatment A and Treatment B in Arthritis, Rheumatoid, sponsored by Pfizer. Completed at 1 site in Singapore. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-04-07.
Sponsored by Pfizer · Phase 1 and Interventional
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's planned enrollment of 30 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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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.
Drug: Treatment A · Drug: Treatment B
Drug: Treatment B · Drug: Treatment A
Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets)
Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet)
Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet)
Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets)
PK parameters: AUCinf, AUClast and Cmax of CP-690,550
Time frame: PK blood samples out to 24 hours post dose in each period
PK parameters: Tmax, AUCt and half-life of CP-690,550
Time frame: Derived from PK blood samples out to 24 hours post dose in each period
Safety: laboratory tests
Time frame: Pre-dose on Day 0 for Period 1 and at 24 hours post last dose in each period
Safety: vital signs
Time frame: Prior to dosing in each period and at 24 hours post last dose in Period 2
Safety: adverse event reporting
Time frame: Throughout study
This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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