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COMPLETED
NCT04468425
PHASE1

Tofacitinib Citrate Topical Gel 3.2% FDA BA Bridging Study

Sponsor: TWi Biotechnology, Inc.

View on ClinicalTrials.gov

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.

Official title: Open-label, Fixed-sequence, Two-period Comparative Bioavailability Study of Tofacitinib From Repeated Topical Applications of Tofacitinib Citrate Topical Gel 3.2% to Single Oral Administration of Xeljanz 5 mg Tablet in Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2020-10-14

Completion Date

2020-12-21

Last Updated

2026-10-15

Healthy Volunteers

Yes

Interventions

DRUG

Tofacitinib Citrate

Period 1: Xelijanz® 5 mg tablet (tofacitinib citrate) for single oral dosing. Period 2: Tofacitinib Citrate Topical Gel 3.2% for repeat topical dosing BID for 14 days.

Locations (1)

Syneos Health Facility

Québec, Canada