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drugset / Trial / NCT04111614

A Study to Demonstrate the Equivalence of the Tofacitinib Oral Solution to the Tablet Formulation in Healthy Participants.

NCT04111614 ↗

Phase 1 Completed 12 enrolled Pfizer
RandomizedCrossoverOpen-labelTreatment

Summary

This is a Phase 1, randomized, open label, 2 period, 2 sequence, cross over, single dose study to evaluate the AUC equivalence, and safety of tofacitinib 5 mL oral solution (1 mg/mL) and 5 mg tablet in healthy participants. Participants will be randomized to 1 of the 2 treatment sequences. A total of approximately 12 healthy male and/or female (non-childbearing potential) participants will be enrolled in the study so that approximately 6 participants will be enrolled in each treatment sequence. Each treatment sequence will consist of 2 periods. In both sequences, participants will remain in the CRU for a total of 5 days and 4 nights (including Period 1 and Period 2).

Timeline

Start
2019-10-11
Primary completion
2019-12-12
Completion
2019-12-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Tofacitinib Small molecule 5 mg Oral

Indications

No indication recorded.