Actively Recruiting
To Evaluate the Adhesion of TK-254RX on Healthy Participants
Led by Teikoku Seiyaku Co., Ltd. · Updated on 2026-01-28
90
Participants Needed
1
Research Sites
5 weeks
Total Duration
On this page
Sponsors
T
Teikoku Seiyaku Co., Ltd.
Lead Sponsor
S
SocraTec R&D GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
To Evaluate the Adhesion of TK-254RX on Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 64 years
- Good state of health
- Provided written informed consent after being informed about the study benefits, risks, and insurance coverage
You will not qualify if you...
- Any injury that restricts body movement
- Excessively hairy skin at the patch application site
- Current or past skin disorders at the application site, such as eczema, neurodermatitis, contact allergy, psoriasis, vitiligo, melanoma, squamous cell carcinoma
- Shaving hair at the application site
- History of excessive sweating or hyperhidrosis at the application site
- Participation in another clinical study within 30 days before this study or concurrently
- Drug or alcohol abuse as judged by the investigator
- Pregnant or lactating women
- Women of child-bearing potential who do not agree to use highly effective contraception methods
- Known hypersensitivity to Esflurbiprofen, R-flurbiprofen, or any excipients of the topical system
- Existing cardiac, hematological, hepatic, renal, or gastrointestinal diseases that may affect safety or tolerability
- Known liver or kidney insufficiency
- History or current treatment of relevant CNS or psychiatric disorders
- Systolic blood pressure below 90 or above 139 mmHg
- Diastolic blood pressure below 60 or above 89 mmHg
- Pulse rate below 50 bpm or above 90 bpm
- Abnormal ECG as assessed by investigator
- Use of any restricted treatments
- Vulnerable subjects such as detainees, close relatives of investigators, employees of sponsor or site
- History of asthma, urticaria, or allergic reactions to aspirin or other NSAIDs
- Known bronchial asthma
- Laboratory values outside normal range
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Deutsche Sporthochschule Köln
Am Sportpark Muengersdorf 6, Clogne, Germany, 50933
Actively Recruiting
Research Team
Y
Yoshiyuki Taneoka
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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