Study to establish the bioequivalence of a new formulation of Asasantin ER compared to the present commercially available Asasantin ER formulation (Aggrenox®)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Area under the concentration-time curve of dipyridamole in plasma over one dosing interval at steady state (AUCτ,ss)
Time frame: up to 17 days
Maximum measured concentration of dipyridamole in plasma at steady state (Cmax,ss)
Time frame: up to 17 days
Minimum measured concentration of dipyridamole in plasma at steady state (Cmin,ss)
Time frame: up to 17 days
Average concentration of dipyridamole in plasma at steady state (Cavg)
Time frame: up to 17 days
Time from dosing to the maximum concentration of dipyridamole in plasma at steady state (tmax,ss)
Time frame: up to 17 days
Peak trough fluctuation of dipyridamole in plasma (PTF)
Time frame: up to 17 days
Amount of the analytes that were eliminated in urine (Ae)
Time frame: up to 24 hours after drug administration
Fraction in percent of dose of the analytes that was eliminated in urine (fe)
Time frame: up to 24 hours after drug administration
Number of subjects with clinically significant changes in 12-lead ECG
Time frame: up to 17 days
Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)
Time frame: up to 17 days
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Number of subjects with clinically significant changes in laboratory tests
Time frame: up to 17 days
Number of subjects with adverse events
Time frame: up to 17 days
Assessment of tolerability by the investigator on a 4-point scale
Time frame: after 17 days