Clinical Pharmacology

Inclusion Criteria

- Healthy male white subjects, 18 to 45 years of age, body mass index ( ≥ 18.0 and ≤ 29.9 kg/m²

Exclusion Criteria

- Subjects with conspicuous findings in medical history and pre-study examination
 - Recent donation of blood/blood components
 - Clinically relevant changes/deviations from normal electrocardiography, physical examination, clinical chemistry, hematology, urinalysis, and/or blood pressure, heart rate (vital signs)
 - Regular daily consumption of an amount of beer, alcohol, xanthine-containing beverages, foods or beverages containing grapefruit and/or cigarettes that may affect study results
 - History of/current relevant diseases of vital or other organs and of the central nervous system and/or medical conditions that would impair subject’s ability to participate in the trial or that may affect study results
 - Subjects with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies or with hypersensitivity to the investigational drugs, the control agent and/or to inactive constituents
 - Regular use of therapeutic or recreational drugs
 - Use of medication within the 2 weeks preceding the study, especially concomitant administration of potassium-sparing diuretics, ACE inhibitors, angiotensin-II-receptor blockers, potassium or calcium supplements, nonsteroidal anti-inflammatory drugs like acetylsalicylic acid, indomethacin or ibuprofen, concomitant use of strong CYP3A4 inducers and inhibitors, weak to moderate CYP3A4 inhibitors
 - Subjects testing positive in the drug screening
 - Subject testing positive for human immunodeficiency virus type 1 and 2 antibody, hepatitis B surface antigen or hepatitis C virus antibody
 - Serum potassium level greater than equal to 5.0 mmol/L, serum sodium level less than equal to 130 mmol/L
 - History of myasthenia gravis, narrow angle glaucoma
 - Known sleep apnea syndrome 
 - Known hereditary galactose intolerance, lactase deficiency or glucose-galactase deficiency
 - Regular intake of liquorice or intake of liquorice within the last 14 days prior study treatment