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

Teikoku Seiyaku

Status and phase

Enrolling

Phase 1

Conditions

Healthy Participants

Treatments

Drug: Esflurbiprofen Topical System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07307794

2025-523577-42-00 (EU Trial (CTIS) Number)

TK-254RX-0107

Details and patient eligibility

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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
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