Evaluation of safety, tolerability and the pharmacodynamic effect after treatment of vericiguat and nitroglycerin
The primary objective of this study was to assess safety and tolerability of this combination.
The secondary objective of this study was to evaluate the pharmacodynamic interaction (effect on BP and HR) between vericiguat 5.0 mg and a 0.2 mg of sublingual nitroglycerin.
- Healthy male subject - Age: 40 to 60 years (inclusive) at the first screening examination - Race: White - Body mass index (BMI): above/equal 18.0 and below/equal 29.9 kg / m²
- Incompletely cured pre-existing diseases for which it could not be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal - History of coronary artery disease (CAD) - Suspected CAD after exercise ECG or echocardiogram, confirmed by external cardiologist - Symptomatic postural hypotension (eg dizziness, lightheadedness) - History of bronchial asthma or other airway disease - Medical disorder that would have impaired the subject´s ability to complete the study in the opinion of the Investigator - Known hypersensitivity to the study drugs (active substances 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
Wuppertal, Germany, 42113
E-mail: [email protected]
Phone: Not Available
Evaluation of the effect of 0.2 mg sublingually administered nitroglycerin after pretreatment with 5 mg vericiguat on safety, tolerability and blood pressure in a randomized, placebocontrolled, double-blind crossover study in two cohorts of healthy male subjects aged 40 to 60 years