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Healthy ParticipantsPhase 1NCT07307794

To Evaluate the Adhesion of TK-254RX on Healthy Participants

A Phase 1 study testing Esflurbiprofen Topical System in people with Healthy Participants, run by Teikoku Seiyaku Co., Ltd. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
Esflurbiprofen Topical System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteGermany
Study dates
19 Jan 2026to 12 Mar 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • age: 18 to 64 years
  • good state of health
  • written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the participants enrolled in the clinical trial

Who cannot join

  • any injury of body which may induce the restriction of body movement
  • excessively hairy skin at application site
  • current or anamnestic known skin disorder (e.g., atopic dermatitis (eczema), neurodermatitis, contact allergy, psoriasis, vitiligo, melanoma, squamous cell carcinoma) or shaving hair at application site, which might interfere with the safety or tolerability of the active ingredient
  • history of excessive sweating/hyperhidrosis inclusive of application site
  • participation in a clinical study within 30 days before inclusion in the study or concomitantly
  • drug or alcohol abuse in the opinion of the investigator
Show all 29Show fewer
  • pregnant and lactating women
  • women of child-bearing potential (WOCBP) who do not agree to apply highly effective contraceptive methods
  • Surgical sterilization
  • Hormonal contraception: combined (estrogen and progestogen containing) hormonal contraception, e.g., oral, intravaginal, transdermal, and progestogen-only hormonal contraception e.g. oral, injectable, implantable as well as intrauterine device (IUD) and intrauterine hormone-releasing system (IUS) each in combination with male condom to increase safety effect (double barrier method))
  • Bilateral tubal occlusion
  • Total abstinence throughout the study at the discretion of the Investigator
  • Periodic abstinence is not an acceptable method of contraception. An acceptable method of contraception must be maintained throughout the study.
  • A woman who is post-menopausal and not surgically sterile must have a negative urine pregnancy test at screening but will not need to comply with an acceptable method of contraception. Women are considered post-menopausal and not of childbearing potential if they had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman had been confirmed by follow up hormone level assessment.
  • known hypersensitivity to Esflurbiprofen, R-flurbiprofen or one of the excipients of the EFTS
  • existing cardiac and/or hematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
  • existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
  • known liver or kidney insufficiency
  • existing gastrointestinal diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
  • history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
  • systolic blood pressure < 90 or > 139 mmHg
  • diastolic blood pressure < 60 or > 89 mmHg
  • pulse rate < 50 bpm or > 90 bpm
  • ECG assessment by investigator: "conspicuous"
  • participants who use any impermissible treatment or for whom restrictions apply
  • subject is vulnerable such as detained or committed to an institution by a court of law or by legal authorities or close affiliation with the sponsor or the investigational site (e.g., a close relative of the investigator, dependent person (e.g., employee of or student at the investigational site), employee of the sponsor or affiliates)
  • subjects who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
  • subject with known bronchial asthma from previous history
  • Laboratory values are out of normal range

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Deutsche Sporthochschule Köln

    Am Sportpark Muengersdorf 6, Clogne, 50933

Other trials in Germany

About this study

Official title: Characterisation of Adhesion Performance of a Newly Developed Esflurbiprofen Topical System (EFTS) - a Phase I, Open-label Study in Healthy Subjects.

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.

Being tested
Esflurbiprofen Topical System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Esflurbiprofen Topical SystemDrug

    The total of one TK-254RX per day for 3 days

Study groups in NCT07307794
Study groupRoleWhat they receive
TK-254RXExperimentalTK-254RX will be applied to the left or right lower leg above the ankle once daily over 3 consecutive days
Receives: Drug: Esflurbiprofen Topical System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Characterization of the patch adhesion

    Measuring the patch adhesion area by percentage visually by site staff, with the patch remaining adhered

    Measured: Day 1 to Day 4

Secondary outcomes (2)

  1. Recording adverse events and serious adverse events

    Characterization of the occurrence of adverse events or serious adverse events of TK-254RX

    Measured: Day 1 to Day 4

  2. Residual amount of S-flurbiprofen

    Residual amount of S-flurbiprofen in the used patch applied on Day 3

    Measured: Day 3 to Day 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2025
  2. Study start19 Jan 2026
  3. Primary completion3 Mar 2026
  4. Study completion12 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07307794
Sponsor's protocol ID
TK-254RX-0107
Other IDs
2025-523577-42-00, 2025
Status last verified
Jan 2026
First submitted
15 Dec 2025
Last updated
27 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Esflurbiprofen Topical System in people with Healthy Participants, run by Teikoku Seiyaku Co., Ltd. at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Characterization of the patch adhesion (time frame: Day 1 to Day 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07307794.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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