Tofacitinib Bioequivalence Study Comparing Tablets And Capsules
- Registration Number
- NCT01599377
- Lead Sponsor
- Pfizer
- Brief Summary
The overall aim of the study is to establish bioequivalence between commercial tofacitinib tablet formulations with the tofacitinib capsule formulation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including oral temperature, BP and PR measurement, 12 Lead ECG and clinical laboratory tests.
Exclusion Criteria
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 2 tofacitinib 5 mg - Cohort 1 tofacitinib 10 mg -
- Primary Outcome Measures
Name Time Method Maximum plasma concentration (Cmax) 24 hours Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf ) 24 hours
- Secondary Outcome Measures
Name Time Method Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) 24 hours Time for Cmax (Tmax) 24 hours Terminal elimination half-life (t½) 24 hours
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇸🇬Singapore, Singapore