To assess the influence of 75 mg Clopidogrel on the pharmacodynamics and safety of 30 mg Lefradafiban tid
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Inhibition of platelet aggregation in platelet rich plasma (PRP)
Time frame: Up to 383:30 hours after first drug administration
Fibrinogen receptor occupancy levels (FRO)
Time frame: Up to 383:30 hours after first drug administration
Maximum concentration of the analyte in plasma at steady state (Cmax)
Time frame: Up to 383:30 hours after first drug administration
Area under the concentration-time curve of the analyte in plasma (AUC)
Time frame: Up to 383:30 hours after first drug administration
Amount of the analyte excreted unchanged in the urine (Ae)
Time frame: Up to 176:00 hours after first drug administration
Number of subjects with adverse events
Time frame: up to 5 days after last drug administration
Changes from baseline in 12-lead ECG
Time frame: Pre-dose and 384:30 hours after first drug administration
Number of subjects with clinically significant findings in vital signs
systolic and diastolic blood pressure, pulse rate
Time frame: up to 5 days after last drug administration
Changes from baseline in bleeding time
Time frame: Pre-dose and 384:30 hours after first drug administration
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