This study is to evaluate the effect of food on the pharmacokinetics of a single dose of ASC41 tablet in healthy volunteers, comparing fasting and postprandial pharmacokinetic parameters of Tmax, Cmax, AUC0-t, AUC0-∞.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Oral tablet
Hunan provincial people's hospital
Changsha, Hunan, China
AUC of ASC41
Evaluate the Area under the plasma concentration versus time curve after single oral dose of ASC41 administered to healthy volunteers.
Time frame: Up to 19 days
Cmax of ASC41
Evaluate the Peak Plasma Concentration after single oral dose of ASC41 administered to healthy volunteers.
Time frame: Up to 19 days
t1/2 of ASC41
Evaluate the Terminal-Phase Half-Life after single oral dose of ASC41 administered to healthy volunteers.
Time frame: Up to 19 days
CL/F of ASC41
Evaluate the Apparent Systemic Clearance after single oral dose of ASC41 administered to healthy volunteers.
Time frame: Up to 19 days
Vd/F of ASC41
Evaluate the Apparent Volume of Distribution after single oral dose of ASC41 administered to healthy volunteers.
Time frame: Up to 19 days
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 19 days
Time frame: Up to 19 days
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