Relative Bioavailability Study

Relative Bioavailability Study of Riociguat Given Orally as a Crushed 2.5 mg Tablet Suspended in Applesauce, Crushed 2.5 mg Tablet Suspended in Water, and Whole 2.5 mg Tablet After a Continental Breakfast in Comparison to a Whole 2.5 mg Tablet Given in the Fasted State to Characterize the Pharmacokinetic Properties in Healthy Male Adult Subjects in a 4-fold Crossover Design

To investigate relative bioavailability of crushed tablets suspended in apple sauce or water

Inclusion Criteria:

• Healthy male subject
• Age: 18 to 45 years (inclusive) at the first screening examination
• Ethnicity: white
• Body mass index (BMI): >18 and <29.9 kg/m2

Exclusion Criteria:

• Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, or effects of the study drug will not be normal
• History of coronary artery disease
• Symptomatic postural hypotension (e.g. dizziness, lightheadedness)
• History of bronchial asthma or any other airway disease
• Smoking (former smokers who have stopped smoking at least 3 months before the first study drug administration may be included)
• Clinically relevant findings in the ECG such as a second- or third-degree atrioventricular block, prolongation of the QRS complex over 120 ms or of the QTc interval (QT interval corrected for heart rate) over 450 ms
• Systolic blood pressure below 100 or above 145 mmHg
• Diastolic blood pressure below 50 or above 95 mmHg
• Heart rate below 45 or above 95 beats per minute