Overview
Tofacitinib Bioequivalence Study Comparing Tablets And Capsules
Status:
Completed
Completed
Trial end date:
2012-07-01
2012-07-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The overall aim of the study is to establish bioequivalence between commercial tofacitinib tablet formulations with the tofacitinib capsule formulation.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
PfizerTreatments:
Tofacitinib
Criteria
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.