Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Sex: male
Ethnic origin: Caucasian
Age: 18 - 55 years, inclusive
Body-mass index1 (BMI): ≥ 19 kg/m² and ≤ 27 kg/m²
Good state of health
Non-smoker or an ex-smoker for a least 1 month
Written informed consent, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subjects participating in the study

Exclusion Criteria:

Safety concerns:

Existing cardiac or haematological diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
Existing hepatic and/or renal diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
Existing gastrointestinal diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
History of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
Pathological ECG (12 standard leads) which might interfere with the safety of the active ingredient
Known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
Subjects with severe allergies or multiple drug allergies
Systolic blood pressure <100/>140 mmHg
Diastolic blood pressure <60/>90 mmHg
Pulse rate <45/>110 bpm
Laboratory values out of normal range unless the deviation from normal is judged as not relevant for the study by the investigator
Positive anti-HIV-test, HBs-AG-test or anti-HCV-test
History of glaucoma
Lack of suitability for the trial 14. Subjects exhibiting extreme genetic polymorphism of CYP 2D6 - "Poor or Ultra-rapid metabolizer" 15. Acute or chronic diseases which could affect absorption or metabolism 16. History of or current drug or alcohol dependence 17. Regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol for male per day 18. Subjects who are on a diet which could affect the pharmacokinetics of the active ingredient 19. Regular intake of caffeine containing food or beverages of ≥ 500 mg per day 20. Blood donation or other blood loss of more than 400 ml within the last two months prior to individual enrolment of the subject 21. Participation in a clinical trial during the last two months prior to individual enrolment of the subject 22. Regular treatment with any systemically available medication (except continuous usual replacement therapy e.g. L-thyroxine) within two weeks prior to the first administration of the study medication 23. Intake of yohimbine for any reason (e.g. fat burning, weight reduction, muscle improvement, post operative care and/or any therapy for erectile dysfunctions) within two weeks prior to first administration of the study medication 24. Subjects, who report a frequent occurrence of migraine attacks
Administrative reasons 25. Subjects suspected or known not to follow instructions 26. 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 study