Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT00855660
Eligibility Criteria:
Inclusion Criteria:
* Healthy male white subjects
* 18 to 45 years of age
* BMI between 18 and 28 kg/m2
* Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period
Exclusion Criteria:
* Relevant deviation from the normal range in the clinical examination; in clinical chemistry, hematology, or urinalysis
* Resting heart rate in the awake subject below 45 BPM or above 90 BPM
* Systolic blood pressure below 100 mmHg or above 145 mmHg
* Diastolic blood pressure above 95 mmHg
* Relevant pathological changes in the ECG such as a second or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QT / QTc-interval over 450 msec for males
* History of genetic muscle or bone disease of any kind
* Completely sedentary or extremely fit subjects
* Fractures in the preceding 12 months
* Psychiatric diseases
* History of peptic ulcers or relevant gastro-esophageal reflux disease
* Subjects with hypersensitivity to the investigational drug riociguat or ranitidine, or to inactive constituents
* Regular daily consumption of more than half a liter of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form, more than 1 L of xanthine-containing beverages, recent smoking history
* Use of medication within the 2 weeks preceding the study which could have interfered with the investigational drug riociguat or ranitidine
* Subjects with a medical disorder, condition or history of such that would have impaired the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00855660
Study Brief:
Protocol Section:
NCT00855660