Relative Bioavailability and Food Effect Study

Relative Bioavailability and Food Effect Study of Two Oral Liquid Formulations in Comparison to a 1 mg Tablet of Riociguat to Characterize Its Pharmacokinetic Properties in Healthy Male and Female Adult Subjects in a Randomized, Open Label, 5-fold Crossover Design

Primary objective: To determine oral bioavailability of the liquid formulation intended for pediatric use and potential food effects in healthy adults.

Secondary objective: To evaluate safety and tolerability measured by physical examination findings, vital signs, electrocardiogram (ECG), laboratory parameters, and adverse events (AEs).

Clinical pharmacology

Inclusion Criteria:

• Healthy male or female volunteers
• Age 18-45 years
• Body mass index (BMI) 18.0-29.9 kg/m²
• Systolic blood pressure (SBP) 110-145 mmHg
• No drugs 2 weeks before treatment
• Nonsmokers for at least 12 weeks

Exclusion Criteria:

• Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
• Medical disorder that would impair the subject's ability to complete the study in the opinion of the Investigator
• Known hypersensitivity to the study drugs (active substance or excipients of the preparations)
• Known severe allergies, non-allergic drug reactions, or multiple drug allergies
• Relevant diseases within the last 4 weeks prior to the first study drug administration
• Regular use of medicines
• Regular use of therapeutic or recreational drugs
• Use of any medication within the 2 weeks preceding the study