The Safety, Tolerability and Pharmacokinetics Study of HEC113995 PA•H2O Tablets in Healthy Male and Female Subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
69
Each dose of HEC113995 PA•H2O tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
Placebo tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
Shanghai Xuhui Central Hospital
Shanghai, China
Safety and Tolerability of HEC113995 PA•H2O by Assessment of the Number of Adverse Events (AEs) Following Administration in Single Ascending Dose
To investigate the safety and tolerability of HEC113995 PA•H2O by assessment of AEs (non-serious and serious) following administration in SAD
Time frame: up to 7 days
PK parameters - AUC0-∞
area under the concentration versus time curve (AUC) from time zero to infinity
Time frame: up to 144 hours
PK parameters - Cmax
Geometric Mean of Maximum Observed Plasma Concentration of HEC113995 PA•H2O
Time frame: up to 144 hours
PK parameters -tmax
time to peak
Time frame: up to 144 hours
PK parameters -t½
apparent terminal elimination half-life
Time frame: up to 144 hours
PK parameters -Vz/F
apparent volume of distribution
Time frame: up to 144 hours
PK parameters - MRT
the Mean Residence Time
Time frame: up to 144 hours
PK parameters -CL/F
the Apparent Clearance
Time frame: up to 144 hours
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