Pharmacodynamic effects on heart rate (HR) at rest and during exercise and on flicker fusion frequency (FFF), FFF method evaluation Safety, tolerability and pharmacokinetics of cilobradine
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
119
Changes in heart rate at rest
Time frame: Pre-dose, up to day 20 after first drug administration
Changes in heart rate during exercise
Time frame: Pre-dose, up to day 20 after first drug administration
Changes in flicker fusion frequency test (FFF)
Time frame: Pre-dose, up to day 20 after first drug administration
Number of patients with clinically relevant changes in laboratory tests
Time frame: Pre-dose, up to 12 days after last drug administration
Number of patients with clinically relevant changes in vital signs (blood pressure, heart rate)
Time frame: Pre-dose, up to 12 days after last drug administration
Number of patients with clinically relevant changes in 12-lead ECG
Time frame: Pre-dose, up to 12 days after last drug administration
Number of patients with adverse events
Time frame: Up to 12 days after last drug administration
Assessment of global tolerability by the investigator
Time frame: Up to 12 days after last drug administration
Changes in peripheral FFF
Time frame: Pre-dose, up to day 20 after first drug administration
Area under the concentration-time curve of the analytes in plasma (AUC)
Time frame: Up to day 20 after start of first drug administration
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Maximum measured concentration of the analytes in plasma (Cmax)
Time frame: Up to day 20 after start of first drug administration
Time from dosing to the maximum concentration of the analytes in plasma (tmax)
Time frame: Up to day 20 after start of first drug administration
Terminal half-life of the analytes in plasma (t½)
Time frame: Up to day 20 after start of first drug administration
Mean residence time of the analytes in the body after oral administration (MRTpo)
Time frame: Up to day 20 after start of first drug administration
Total clearance of the analytes in plasma following extravascular administration (CL/F)
Time frame: Up to day 20 after start of first drug administration
Apparent volume of distribution of the analytes during the terminal phase λz following extravascular administration (Vz/F)
Time frame: Up to day 20 after start of first drug administration