Thrombosis is a maladaptive process of vascular occlusion and remains a primary cause of cardiovascular morbidity and mortality, The dose-limiting issue with available anticoagulant therapies is bleeding. The primary objective of this study is to assess the safety and tolerability of SHR2285 tablets in healthy subjects. In addition, this study will provide information on Pharmacokinetics and Pharmacodynamics of SHR2285 tablets in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
28
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Number of subjects with adverse events and serious adverse events
Time frame: Pre-dose to 7 days after dose administration
Area under the plasma concentration versus time curve (AUC) of SHR2285
Time frame: Pre-dose to 2 days after dose administration
Maximum observed serum concentration (Cmax) of SHR2285
Time frame: Pre-dose to 2 days after dose administration
Time to maximum observed serum concentration (Tmax) of SHR2285
Time frame: Pre-dose to 2 days after dose administration
Time to elimination half-life (T1/2) of SHR2285
Time frame: Pre-dose to 2 days after dose administration
Apparent total clearance of the drug from plasma after oral administration(CL/F) of SHR2285
Time frame: Pre-dose to 2 days after dose administration
Apparent volume of distribution after non-intravenous administration (V/F) of SHR2285
Time frame: Pre-dose to 2 days after dose administration
Mean Residence Time(MRT) of SHR2285
Time frame: Pre-dose to 2 days after dose administration
Change of APTT, PT, INR from baseline.
Time frame: during Pre and Post-dose
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