Tofacitinib Citrate Topical Gel 3.2% FDA BA Bridging Study
Status:
Recruiting
Trial end date:
2021-06-15
Target enrollment:
Participant gender:
Summary
This is a Phase 1, single center, open-label, fixed sequence, two-period pharmacokinetic (PK)
study to evaluate the safety and relative systemic bioavailability of topical and oral
tofacitinib formulations in approximately 14 healthy subjects. Participants will receive a
single oral dose of tofacitinib 5 mg tablet in Period 1 of the study followed by a 7-day
washout period. In Period 2, participants will receive repeat administration of Tofacitinib
Citrate Topical Gel 3.2% BID for 14 days.