Tofacitinib Citrate Topical Gel 3.2% FDA BA Bridging Study

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.

Timeline

Start

2020-10-14

Primary completion

2020-12-21

Completion

2020-12-21

Drugs

Indications

No indication recorded.