drugset / Trial / NCT03112148

PK Study in Adult Healthy Volunteers to Assess QD Dosing With the Selected Age-appropriate MR Formulations

NCT03112148

Phase 1 Completed 24 enrolled Pfizer
RandomizedCrossoverOpen-labelTreatment

Summary

This is a Phase 1, randomized, open label, 4-period, 6-sequence, partial cross-over, single-dose study to evaluate the PK of age-appropriate tofacitinib MR formulations (release rates: MR-Slow, MR-Moderate, and MR-Fast) compared to tofacitinib IR solution under fasting conditions. The effect of food on the PK of MR-Slow and MR-Fast will also be assessed.

Timeline

Start
2017-09-11
Primary completion
2017-11-15
Completion
2017-11-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Tofacitinib Small molecule 10 mg Oral

Indications

No indication recorded.