Study to investigate pharmacokinetics, pharmacodynamics and safety of RAD-SP capsule in multiple administration to healthy adult male volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Asasantin® extended release (RAD-SP)
Area under the plasma drug concentration-time curve at steady state (AUCss)
Time frame: up to 144 hours after first drug administration
Maximum drug plasma concentration at steady state (Cmax,ss)
Time frame: up to 144 hours after first drug administration
Cmax,ss/AUCss
Time frame: up to 144 hours after first drug administration
Minimum drug plasma concentration at steady state (Cmin,ss)
Time frame: up to 144 hours after first drug administration
Time to reach Cmax (tmax)
Time frame: up to 144 hours after first drug administration
Terminal half-life (t1/2)
Time frame: up to 144 hours after first drug administration
Mean residence time (MRT)
Time frame: up to 144 hours after first drug administration
Percent peak trough fluctuation (%PTF)
Time frame: up to 144 hours after first drug administration
Platelet adenosine uptake inhibition rate (AUI)
Time frame: up to 74 hours after first drug administration
Malondialdehyde (MDA) production inhibition rate
Time frame: up to 74 hours after first drug administration
Thromboxane B2 (TXB2) production inhibition rate
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 74 hours after first drug administration
Number of subjects with adverse events
Time frame: up to 14 days after first drug administration
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 14 days after first drug administration
Number of subjects with abnormal changes in vital signs
Time frame: up to 14 days after first drug administration
Number of subjects with abnormal changes in electrocardiogram findings
Time frame: up to 14 days after first drug administration