PK and Bioavailability Comparison of Tofacitinib Between a Modified Release and The Immediate Release Formulation

PHASE1CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

December 3, 2018

Primary Completion Date

February 12, 2019

Study Completion Date

February 12, 2019

Conditions
Healthy
Interventions
DRUG

tofacitinib MR 11 mg

Single oral dose of tofacitinib MR 11 mg, administered as 1 x MR 11 mg tablet, in a fasting state on Day 1 followed by once daily dosing (QD) on Days 3, 4, 5, 6 and 7.

DRUG

tofacitinib IR 5 mg

Two separate oral doses (12 hours apart) of tofacitinib IR 5 mg, administered one in the morning in a fasting state and one in the evening at least 2 hours after dinner on Day 1 followed by 5 mg IR every 12 hours on Days 3, 4, 5, 6 and 7.

Trial Locations (1)

201203

Shuguang Hospital Affiliated to Shanghai University of TCM/Phase I Unit, Shanghai

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT04403776 - PK and Bioavailability Comparison of Tofacitinib Between a Modified Release and The Immediate Release Formulation | Biotech Hunter | Biotech Hunter