Cannabidiol Bioavailability Trial With Oral Multiple Dose Administration

Inclusion Criteria: 1. ethnic origin: Caucasian 2. age: 18 years or older (including) 3. body-mass index (BMI): \>= 18.5 kg/m² and \<= 30.0 kg/m² 4. good state of health 5. non-smoker or ex-smoker for at least 1 month 6. 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 hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient 3. existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient 4. history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders 5. hepatic impairment 6. history of bradycardia, tachycardia or other arrhythmic symptoms of clinical significance 7. Nurses Global Assessment of Suicide Risk (NGASR)-scale showing a high or very high risk 8. known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations 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 for men and \> 470 ms for women 14. 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) 15. all other laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator 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 within the last 14 days prior to individual enrolment of the subject 18. contact to persons in foreign risk regions as defined by the Robert Koch Institute within the last 14 days prior to individual enrolment of the subject 19. known direct contact with insufficient protection to persons with diagnosis of COVID-19 within the last 14 days prior to individual enrolment upon reporting of the subject Lack of suitability for the clinical trial 20. acute or chronic diseases which may interfere with the pharmacokinetics of the IMP 21. history of or current drug or alcohol dependence 22. positive alcohol, cotinine or drug test at screening examination 23. regular intake of alcoholic food or beverages of ≥ 24 g pure ethanol for male or ≥ 12 g pure ethanol for female per day 24. subjects who are on a diet which could affect the pharmacokinetics of the active ingredient 25. regular intake of caffeine containing food or beverages of ≥ 500 mg caffeine per day 26. blood donation or other blood loss of more than 400 ml within the last 2 months prior to individual enrolment of the subject 27. administration of any investigational medicinal product during the last 2 months prior to individual enrolment of the subject 28. regular treatment with any systemically available medication (except hormonal contraceptives and hormonal replacement therapy, e.g. estrogens, L-thyroxine) 29. subjects, who report a frequent occurrence of migraine attacks For female subjects with childbearing potential only: 30. positive pregnancy test at screening examination 31. pregnant or lactating women 32. female subjects who do not agree to apply highly effective contraceptive methods Administrative reasons 33. subjects suspected or known not to follow instructions 34. 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