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).
- 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
- 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
MEDA Manufacturing GmbH, ClinPharmCologne
Köln, Germany, 51063
E-mail: [email protected]
Phone: Not Available
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