Trial Condition(s):

Healthy Volunteers

Relative bioavailability study

Bayer Identifier:

17306

ClinicalTrials.gov Identifier:

NCT02159313

EudraCT Number:

2013-005166-18

Study Completed

Trial Purpose

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

Trial Summary

Enrollment Goal
48
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Mönchengladbach, Germany, 41061

Status
Completed
 

Trial Design