Relative bioavailability and food interaction study of BAY1021189
- Pharmacokinetics of BAY 1021189 after single oral doses of 1.25 mg and 5 mg immediate release tablets in comparison to 5 mg administered as oral solution
- Influence of food (high-fat, high-calorie breakfast) on the pharmacokinetics of BAY 1021189 after single oral administration of a 5 mg IR tablet.
- Safety, tolerability and pharmacodynamics of BAY 1021189.
- Healthy white male volunteers, age 18-45 years, body mass index: ≥ 18 and ≤ 29.9 kg/m²
- Recent donation of blood/blood components - Clinically relevant changes/deviations from normal ECG, 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 - Subjects with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies or with hypersensitivity to the investigational drug, 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 which could interfere with the investigational product - Subjects testing positive in the drug screening - Incompletely cured pre-existing diseases for which it could be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs were not be normal - Subject testing positive for human immunodeficiency virus type 1 and 2 antibody, hepatitis B surface antigen or hepatitis C virus antibody - Special diets preventing the subjects from eating the standard meals during the study - History of postural syncopes
Wuppertal, Germany, 42113
E-mail: [email protected]
Phone: Not Available
Relative bioavailability study to investigate safety, tolerability, pharmacodynamics and pharmacokinetics of 1.25 mg and 5 mg BAY 1021189 IR tablets in comparison to 5 mg oral solution, and to investigate the influence of a high fat, high calorie meal on the 5 mg IR tablet in 16 healthy male subjects in a single dose, randomized, open-label, four-fold cross-over design