Clinical Pharmacology

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

- Recent donation of blood/blood components - Subjects hypersensitive to investigational drugs, their components and/or with a history of multiple drug allergies, non-allergic drug reactions, or severe allergies
- Galactose and fructose intolerance
- Lactase, saccharase-isomaltase or vitamin B12 deficiency, hypo- or hyperchlorhydria, hypophosphatemia, porphyria
- Medical conditions/disorder/illness that would impair subject’s ability to participate in the trial or that may affect study results - Positive testing in drug screening - Subject is tested to be human immunodeficiency virus 1/2 antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies positive - Clinically relevant changes/deviations from normal range in electrocardiogram, clinical examination, clinical chemistry, hematology, urinalysis, serum potassium ≥5.0 mmol/L, serum sodium ≤130 mmol/L, and/or vital signs (blood pressure, heart rate) - Regular daily consumption of a certain amount of beer, alcohol, cigarettes, xanthine or grapefruit-containing beverages that may affect study results - Regular use of therapeutic or recreational drugs - Use of medication within the 2 weeks preceding the study which could have interfered with the investigational product; especially concomitant use of: Potassium-sparing diuretics, ACE inhibitors, angiotensin-II-receptor blockers, potassium or calcium supplements, non-steroidal anti-inflammatory drugs, strong CYP3A4 inducers, Weak to moderate CYP3A4 inhibitors, strong inhibitors of CYP3A4 or strong inhibitors of CYP2C8, macrolide antibiotics, digoxin, warfarin, terfenadine,
astemizole, cyclosporine, cisapride, tacrolimus or atazanavir, prokinetic or anticholinergic drugs