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Open label study to investigate patch adhesion of an Esflurbiprofen-containing patch in healthy volunteers
EU CTIS ID: 2023-503609-12-00
What this study is testing
Characterization of adhesion 5 min prior to removal by the adhesion assessment by site staff with EFTS marked by site staff
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. age: 18 to 64 years
- 2. good state of health
- 3. non-smoker or ex-smoker for at least 3 months
- 4. 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 subjects participating in the clinical trial
You likely can't join if
- 1. any injury of body which may induce the restriction of body movement
- 10. existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- 11. existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- 12. known liver or kidney insufficiency
- 13. existing gastrointestinal diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- 14. history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
See the full eligibility criteria
- 1. age: 18 to 64 years
- 2. good state of health
- 3. non-smoker or ex-smoker for at least 3 months
- 4. 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 subjects participating in the clinical trial
- 1. any injury of body which may induce the restriction of body movement
- 10. existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- 11. existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- 12. known liver or kidney insufficiency
- 13. existing gastrointestinal diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- 14. history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
- 15. systolic blood pressure < 90 or > 139 mmHg
- 16. diastolic blood pressure < 60 or > 89 mmHg
- 17. pulse rate < 50 bpm or > 90 bpm
- 18. subjects who use any impermissible medication (defined in the study protocol)
- 2. excessively hairy skin at application site
- 3. current skin disorder or shaving hair at application site
- 4. history of excessive sweating/hyperhidrosis inclusive of application site
- 5. participation in a clinical study within 30 days before inclusion in the study or concomitantly
- 6. drug or alcohol abuse in the opinion of the investigator
- 7. pregnant and lactating women
- 8. women of child-bearing potential who do not agree to apply highly effective contraceptive methods (as defined in the clinical trial protocol)
- 9. known hypersensitivity to Esflurbiprofen R-flurbiprofen or one of the excipients of the EFTS
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.