Trial Condition(s):
Healthy Volunteers
Relative bioavailability study
Bayer Identifier:
17306
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Mönchengladbach, Germany, 41061 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
4
Primary Outcome
- Pharmacokinetics of riociguat in plasma by Area under the plasma concentration time curve (AUC)Timeframe: Multiple time points up to day 3
- Pharmacokinetics of riociguat in plasma by maximal concentration (Cmax)Timeframe: Multiple time ponits up to day 3
Secondary Outcome
- Number of participants with adverse events as a measure of safety and tolerabilityTimeframe: Up to 12 weeks
Additional Information
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