A Study to Demonstrate the Equivalence of the Tofacitinib Oral Solution to the Tablet Formulation in Healthy Participants.
Status:
Completed
Trial end date:
2019-12-12
Target enrollment:
Participant gender:
Summary
This is a Phase 1, randomized, open label, 2 period, 2 sequence, cross over, single dose
study to evaluate the AUC equivalence, and safety of tofacitinib 5 mL oral solution (1 mg/mL)
and 5 mg tablet in healthy participants. Participants will be randomized to 1 of the 2
treatment sequences. A total of approximately 12 healthy male and/or female (non-childbearing
potential) participants will be enrolled in the study so that approximately 6 participants
will be enrolled in each treatment sequence. Each treatment sequence will consist of 2
periods. In both sequences, participants will remain in the CRU for a total of 5 days and 4
nights (including Period 1 and Period 2).