To Evaluate the Adhesion of TK-254RX on Healthy Participants
Characterisation of Adhesion Performance of a Newly Developed Esflurbiprofen Topical System (EFTS) - a Phase I, Open-label Study in Healthy Subjects.
Sponsor study identifier
Secondary identifiers
CTIS
NIH
interventional
90
1 country
1
Study Start
January 19, 2026
Actual (reported)Primary Completion
March 3, 2026
Actual (reported)Study Completion
March 12, 2026
Actual (reported)This study is a single-center, open-label, multiple-dose trial in healthy participants. The primary purpose of this study is to assess the adhesion of TK-254RX. Secondary purposes are to assess the safety of TK-254RX and the residual amount of the patch.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 12, 2026
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 15, 2025
Actual (reported)December 29, 2025
Actual (reported)January 19, 2026
Actual (reported)March 3, 2026
Actual (reported)March 12, 2026
Actual (reported)Characterization of the patch adhesion
Measuring the patch adhesion area by percentage visually by site staff, with the patch remaining adhered
Day 1 to Day 4
Recording adverse events and serious adverse events
Day 1 to Day 4
Residual amount of S-flurbiprofen
Day 3 to Day 4
TK-254RX will be applied to the left or right lower leg above the ankle once daily over 3 consecutive days
The total of one TK-254RX per day for 3 days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Deutsche Sporthochschule Köln
Am Sportpark Muengersdorf 6, Clogne, 50933, Germany
Kenichi Nishiyama
Teikoku Seiyaku Co., Ltd.
90 participants (actual enrollment reported by the registry).
First Submitted
December 15, 2025
First Posted
December 29, 2025
Study Start
January 19, 2026
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
March 3, 2026
Actual (reported)Study Completion
March 12, 2026
Actual (reported)Last Updated
August 27, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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