NCT04111614 is a Phase 1 clinical trial of Tofacitinib tablet in Healthy, sponsored by Pfizer.

Who is sponsoring NCT04111614?

NCT04111614 is sponsored by Pfizer.

What drugs are being tested in NCT04111614?

Interventions in NCT04111614: Tofacitinib tablet, Tofacitinib Oral Solution.

Is NCT04111614 still recruiting?

NCT04111614 is currently completed. Last updated 13 January 2020.

Last reviewed 2020-01-13 · How we verify

NCT04111614

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 13 January 2020

What this trial tests

Phase 1 trial testing Tofacitinib tablet in Healthy in 12 participants. Completed in 12 December 2019.

Timeline

11 October 2019

Primary endpoint
12 December 2019

12 December 2019

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	11 October 2019
Primary completion	12 December 2019
Estimated completion	12 December 2019
Sites	1 location across United States

Drugs / interventions tested

Tofacitinib tablet — full drug profile →
Tofacitinib Oral Solution

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Tofacitinib pharmacokinetics in children and adolescents with juvenile idiopathic arthritis.
Chang C, Vong C, Wang X, Hazra A, et al · · 2024 · cited 4× · PMID 38298058 · DOI 10.1002/psp4.13104

Verify or expand the search:

Other trials of Tofacitinib tablet

Trials testing the same drug.

NCT04299971 — Efficiency of Methotrexate and Tofacitinib in Mild and Moderate Patients · Phase 4 · unknown

Other recruiting trials for Healthy

Currently open trials in the same condition.

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NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other Pfizer trials

Trials by the same sponsor.

NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna® · not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04111614 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 13 January 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04111614.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing