| Eligibility |
Inclusion Criteria:
1. age: 18 to 64 years (inclusive)
2. body-mass index (BMI): >= 18.5 kg/m² and <= 30.0 kg/m²
3. good state of health
4. non-smoker or ex-smoker for at least 3 months
5. 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
Exclusion Criteria:
Safety concerns
1. existing cardiac and/or haematological diseases or pathological findings, which might
interfere with the safety or tolerability of the active ingredient
2. existing or history of hypertension and/or heart failure
3. existing hepatic and/or renal diseases or pathological findings, which might interfere
with the safety or tolerability, and/or pharmacokinetics of the active ingredient
4. existing gastrointestinal diseases or pathological findings, which might interfere
with the safety, tolerability, absorption and/or pharmacokinetics of the active
ingredient
5. history of gastrointestinal bleeding or perforation related to previous NSAID therapy
6. active, or history of, ulcerative colitis, Crohn's disease, peptic ulceration or
gastrointestinal haemorrhage
7. existing metabolic, endocrine and/or immunologic diseases or pathological findings,
which might interfere with the safety or tolerability, and/or pharmacokinetics of the
active ingredient
8. diabetes mellitus
9. hyperlipidaemia (LDL > 160 mg/dL; HDL < 35 mg/dL; triglycerides > 200 mg/dL;
cholesterol > 240 mg/dL)
10. history of relevant CNS and/or psychiatric disorders and/or currently treated CNS
and/or psychiatric disorders
11. presence or history of acute or chronic diseases of the skin (e.g. atopy,
neurodermatitis, contact allergy, eczema, psoriasis, vitiligo, melanoma, squamous cell
carcinoma), any dermatological condition or skin sensitivity which might interfere
with the safety, tolerability, absorption and/or pharmacokinetics of the active
ingredient
12. existing or history of bronchial asthma
13. known allergic reactions (e.g. bronchospasm, rhinitis, angioedema, or urticaria) to
the active ingredients used, to acetylsalicylic acid or other NSAIDs, or to
constituents of the pharmaceutical preparations
14. history of severe allergies or multiple drug allergies unless it is judged as not
relevant for the clinical trial by the investigator
15. fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase
insufficiency
16. galactose intolerance or Lapp lactase deficiency
17. systolic blood pressure < 90 or > 139 mmHg
18. diastolic blood pressure < 60 or > 89 mmHg
19. heart rate < 50 bpm or > 90 bpm
20. QTc interval > 450 ms for men and > 470 ms for women
21. laboratory values out of normal range unless the deviation from normal is judged as
not relevant for the clinical trial by the investigator
22. ASAT > 20% ULN, ALAT > 10% ULN, bilirubin > 20% ULN (except in case of existing Morbus
Gilbert-Meulengracht deduced from anamnesis/medical history) and creatinine > 0.1
mg/dL ULN (limit of > 0.1 mg/dL correspondents to of > 9 µmol/l ULN).
23. positive anti-HIV-test (if positive to be verified by western blot), HBs-AG-test or
anti-HCV-test
24. symptoms of, or diagnosis of COVID-19 within the last 14 days prior to individual
enrolment of the subject
25. contact to persons in risk regions as defined by the Robert Koch Institute within the
last 14 days prior to individual enrolment of the subject
26. direct contact to persons with symptoms of, or diagnosis of COVID-19 within the last
14 days prior to individual enrolment of the subject Lack of suitability for the
clinical trial
27. skin abnormality (e.g. tattoo (including tattoo that was removed), scar, sunburn or
obvious difference in skin colour), open sores, or excessive hair at the application
site
28. acute or chronic diseases which may interfere with the pharmacokinetics of the IMP
29. history of or current drug or alcohol dependence
30. positive alcohol or drug test at screening examination
31. regular intake of alcoholic food or beverages of >= 24 g pure ethanol for male or >=
12 g pure ethanol for female per day
32. subjects who are on a diet which could affect the pharmacokinetics of the active
ingredient
33. regular intake of caffeine containing food or beverages of >= 500 mg caffeine per day
34. blood donation or other blood loss of more than 400 ml within the last 2 months prior
to individual enrolment of the subject
35. administration of any investigational medicinal product during the last 2 months prior
to individual enrolment of the subject
36. regular treatment with any systemically available medication (except hormonal
contraceptives and hormonal replacement therapy, e.g. estrogens, L-thyroxine)
37. subjects, who report a frequent occurrence of migraine attacks
For female subjects with childbearing potential only:
38. positive pregnancy test at screening examination
39. pregnant or lactating women
40. female subjects who do not agree to apply highly effective contraceptive methods
Administrative reasons
41. subjects suspected or known not to follow instructions
42. subjects who are unable to understand the written and verbal instructions, in
particular regarding the risks and inconveniences they will be exposed to during their
participation in the clinical trial
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