BAY1021189, Omeprazol/Antacida Interaction Study
To investigate the influence of a co-administration of a single dose of 10 mL Maalox® 70 mVal Suspension and a 4 day pre- and one time co-treatment of 2 x 20 mg Antra® once daily on the pharmacokinetics of 5 mg BAY 1021189 in comparison to 5 mg BAY 1021189 alone, both given orally as 4 x 1.25 mg immediate release tablets, in a three-fold crossover, randomized, open label design in healthy male subjects.
Secondary objectives: To assess safety and tolerability of BAY 1021189.
- Healthy, white male subjects, 18 to 45 years of age, body mass index: between ≥18.0 and ≤29.9 kg/m2
- 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 - Incompletely cured pre-existing diseases for which it could have been assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs were not normal - 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 testing positive in the drug screening - Positive urine drug screening - Special diets preventing the subjects from eating the standard meals during the study
Wuppertal, Germany, 42096
E-mail: [email protected]
Phone: Not Available
Interaction study to investigate the influence of a co-administration of a single dose of 10 mL Maalox® and a 4 days pre- and co-treatment with Antra® 2 x 20 mg OD, respectively, on the pharmacokinetics of a single dose of 5 mg BAY 1021189, taken as 4 x 1.25 mg IR tablets, in a threefold crossover, randomized, open label design in healthy male subjects