Clinical Pharmacology

- Healthy male white subjects; 18 to 46 years of age; body mass index: ≥18 and ≤29.9 kg/m*2

- Clinically relevant changes/deviations from normal ECG, clinical examination, clinical chemistry, hematology, urinalysis, and/or blood pressure, heart rate (vital signs), or physical examination
- Regular use of therapeutic or recreational drugs
- Positive testing in drug screening and or alcohol breath test
- Recent donation of blood/blood components
- Subjects hypersensitive to the investigational drugs, their components and/or with a history of multiple drug allergies, non-allergic drug reactions, or severe allergies
- History of / current relevant diseases of vital organs or of the central nervous system and/or medical conditions/disorder/illness that would impair subject’s ability to participate in the trial or that may affect study results, diagnosed malignancy, psychiatric disorders
- Regular daily consumption of an amount of beer, alcohol, xanthine-containing beverages, and/or cigarettes that may affect study results
- Intake of foods or beverages containing grapefruit within 2 weeks before study drug administration
- Regular use of medicines and use of medication within the 2 weeks preceding the study, especially strong CYP3A4 inducers, weak to moderate CYP3A4 inhibitors and strong inhibitors of CYP3A4 or strong inhibitors of CYP2C8
- Excluded therapies (eg physiotherapy, acupuncture, etc)
- Clinically relevant findings in the physical examination
- Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2) (under Laboratory examinations)
- Serum potassium level greater than equal to 5.0 mmol/L or serum sodium level less than equal to130 mmol/L