Comparative pharmacokinetics of dipyridamole in two new formulations of Asasantin ER compared to the present commercial formulation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
Area under the concentration-time curve of dipyridamole in plasma at steady state (AUC,ss)
Time frame: Up to 48 hours after start of drug administration
Percent peak trough fluctuation of dipyridamole in plasma (%PTF)
Time frame: Up to 48 hours after start of drug administration
Maximum concentration of the analytes in plasma at steady state (Cmax,ss)
Time frame: Up to 48 hours after start of drug administration
Minimum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time frame: Up to 48 hours after start of drug administration
Time from dosing to the maximum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ Time from dosing to the maximum measured concentration of the analytes in plasma at steady state (tmax,ss)
Time frame: Up to 48 hours after start of drug administration
Percent area under the curve fluctuation of the analytes in plasma (AUCfluct)
Time frame: Up to 48 hours after start of drug administration
Terminal half-life of the analytes in plasma (t1/2)
Time frame: Up to 48 hours after start of drug administration
Percent of dose of the analytes recovered unchanged in urine (Ae%)
Time frame: Up to 24 hours after start of drug administration
Ratio of peak concentration of the analytes in plasma over area under the curve at steady state (Cmax,ss / AUC,ss)
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Time frame: Up to 48 hours after start of drug administration
Number of subjects with clinically relevant changes in vital signs (blood pressure, pulse rate)
Time frame: up to 8 days after last study drug administration
Number of subjects with clinically relevant changes in 12-lead ECG
Time frame: up to 8 days after last study drug administration
Number of subjects with clinically relevant changes in laboratory values
Time frame: up to 8 days after last study drug administration
Number of subjects with adverse events
Time frame: up to 8 days after last study drug administration