Relative Bioavailability Study

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Riociguat

Criteria

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