| Eligibility |
Inclusion Criteria:
1. sex: male
2. age: 18 -55 years, inclusive
3. body-mass index2 (BMI): >=18.5 kg/m² and <= 30.0 kg/m²
4. body weight >= 65 kg
5. good state of health as determined by no clinically significant diseases captured in
the medical history or evidence of clinically significant findings on physical
examination (including vital sign) and/or ECG, as determined by the investigator
6. non-smoker or ex-smoker for at least 1 month
7. 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:
1. existing cardiac and/or haematological diseases or pathological findings, which might
interfere with the safety or tolerability of the active ingredient (especially sick
sinus syndrome or conduction defects such as sino-atrial block, atrio-ventricular
block (second degree or higher)) or concomitant treatment with beta-blockers
2. existing hepatic and/or renal diseases or pathological findings, which might interfere
with the safety or tolerability, and/or pharmacokinetics of the active ingredient
(especially predisposition to urinary obstruction and seizures or subjects suffering
from overactive bladder treated with anticholinergics)
3. existing gastrointestinal diseases or pathological findings, which might interfere
with the safety, tolerability, absorption and/or pharmacokinetics of the active
ingredient (especially active gastric or duodenal ulcers or predisposition to these
conditions)
4. history of relevant CNS and/or psychiatric disorders and/or currently treated CNS
and/or psychiatric disorders, e.g. depression treated with tricyclic antidepressants,
or psychosis treated with neuroleptics (cave! Metoclopramide), Parkinson's disease and
predisposition to seizures
5. history of chronic obstructive or other pulmonary diseases or bronchial asthma
6. acute or history of narrow-angle glaucoma, currently treated open-angle glaucoma, or
any indications from case history that there might be raised intra-ocular pressure
(e.g. pressure pain, blurred vision, glaucomatous halo)
7. subjects suffering from pyloric stenosis or having difficulty in passing water owing
to an impeded flow of urine (e.g. in diseases of the prostate), as well as subjects
with intestinal obstruction, arrhythmia, pronounced bradycardia and severe cerebral
sclerosis as well as metabolic diseases
8. known allergic reactions to the active ingredients used or to constituents of the
pharmaceutical preparations or previous history of application site reactions
suggestive of allergic contact dermatitis with rivastigmine patch or scopolamine patch
9. history of severe allergies or multiple drug allergies unless it is judged as not
relevant for the clinical trial by the investigator
10. systolic blood pressure < 90 or > 139 mmHg
11. diastolic blood pressure < 60 or > 89 mmHg
12. heart rate < 50 bpm or > 90 bpm
13. QTc interval > 450 ms (according to Fridericia formula)
14. laboratory values out of normal range unless the deviation from normal is judged as
not relevant for the clinical trial by the investigator
15. 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).
16. positive anti-HIV-test (if positive to be verified by western blot), HBs-AG-test or
anti-HCV-test
17. diagnosis of COVID-19 and/or persisting disease symptoms (e.g., fever, cough) at the
Investigator's discretion; current state or federal COVID-19 regulations will be
considered.
18. participation in a clinical trial with administration of any investigational medicinal
product during the last 2 months prior to individual enrolment of the subject
19. simultaneous participation in another clinical trial with active ingredients Lack of
suitability for the clinical trial
20. presence or history of acute or chronic diseases especially of the skin, which could
affect dermal absorption or metabolism, which may interfere with the bioavailability
and /or the pharmacokinetics of the IMP or NIMP based on assessment of the
investigator
21. skin abnormality (e.g. tattoo or scar) at the application site
22. acute or chronic diseases which may interfere with the pharmacokinetics of the IMP
23. history of or current drug or alcohol dependence
24. positive alcohol or drug test at screening examination
25. regular intake of alcoholic food or beverages of = 24 g pure ethanol per day
26. subjects who are on a diet which could affect the pharmacokinetics of the active
ingredient
27. regular intake of caffeine containing food or beverages of = 500 mg caffeine per day
28. blood donation or other blood loss of more than 400 ml within the last 2 months prior
to individual enrolment of the subject
29. regular treatment with any systemically available medication (except replacement
therapy, e.g. L-thyroxine)
30. subjects practising top-performance sports (more than 4 x 2h per week) Administrative
reasons
31. 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
32. subjects suspected or known not to follow instructions
33. 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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