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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
30
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)
Pfizer Investigational Site
Singapore, Singapore
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 platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.