The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects.
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single \& Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of Kangdaprevir Sodium Tablet in Healthy Adult Subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Tablet,administered orally once daily
Tablet,administered orally once daily
the First Hospital of Jilin University
Changchun, Jilin, China
Adverse events
To assess the tolerability after a single and multiple dose of HEC84048
Time frame: Baseline to day 13
Cmax
Maximum observed plasma concentration of HEC84048
Time frame: predose to 72 hour after dosing
Tmax
Time of the maximum observed plasma concentration of HEC84048
Time frame: predose to 72 hour after dosing
AUC
Area under the plasma concentration-time curve (AUC)
Time frame: predose to 72 hour after dosing
T1/2
Terminal elimination half-life
Time frame: predose to 72 hour after dosing
Vz/F
Apparent volume of distribution
Time frame: predose to 72 hour after dosing
CL/F
Oral clearance
Time frame: predose to 72 hour after dosing
MRT
Mean Residence Time
Time frame: predose to 72 hour after dosing
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