drugset / Trial / NCT04403776

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

NCT04403776

Phase 1 Completed 26 enrolled Pfizer
RandomizedCrossoverOpen-labelOther

Summary

A study to characterize the single-dose and steady-state pharmacokinetics of tofacitinib Modified Release (MR) formulation as well as to compare the extent of absorption of the MR 11 mg formulation (once daily) to that of the Immediate Release (IR) 5 mg formulation (twice daily) of tofacitinib in Chinese healthy subjects under fasted conditions.

Timeline

Start
2018-12-03
Primary completion
2019-02-12
Completion
2019-02-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Tofacitinib Small molecule 5 mg Oral
Subject Tofacitinib Small molecule 11 mg Oral

Indications

No indication recorded.