The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets in Chinses Healthy Subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
74
Each dose of HEC83518 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
placebo
The Shanghai xuhui district central hospital
Shanghai, Shanghai Municipality, China
The Number of Adverse Events (AEs)
Safety and Tolerability of HEC83518 by Assessment of the Number of Adverse Events (AEs) Following Administration in Single Ascending Dose .
Time frame: up to 5 days
PK parameters - AUC0-∞
area under the concentration versus time curve (AUC) from time zero to infinity
Time frame: up to 96 hours
PK parameters - Cmax
Geometric Mean of Maximum Observed Plasma Concentration of HEC83518
Time frame: up to 96 hours
PK parameters -tmax
time to peak
Time frame: up to 96 hours
PK parameters -t½
apparent terminal elimination half-life
Time frame: up to 96 hours
PK parameters -Vz/F
apparent volume of distribution
Time frame: up to 96 hours
PK parameters - MRT
the Mean Residence Time
Time frame: up to 96 hours
PK parameters -CL/F
the Apparent Clearance
Time frame: up to 96 hours
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