To evaluate the safety and tolerability of RSS0343 tablets in healthy subjects after single and multiple oral administration
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
RSS0343 tablets and placebo were given orally as a single dose
RSS0343 tablets and placebo were taken orally multiple times
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)
Shandong, Jinan, China
adverse events
Time frame: The observation lasted until the 61th day
Cmax
Time frame: The observation lasted until the 33th day
AUC0-t
Time frame: The observation lasted until the 33th day
AUC0-inf
Time frame: The observation lasted until the 33th day
Tmax
Time frame: The observation lasted until the 33th day
t1/2
Time frame: The observation lasted until the 33th day
CL/F
Time frame: The observation lasted until the 33th day
Vz/F
Time frame: The observation lasted until the 33th day
Ae,urine
Time frame: The observation lasted until the 33th day
fe,urine
Time frame: The observation lasted until the 33th day
Relative bioavailability of premeal and postmeal administration
Time frame: The observation lasted until the 16th day
Neutrophil elastase (NE) activity in peripheral blood after repeated oral administration of RSS0343
Time frame: The observation lasted until the 61th day
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