To evaluate the pharmacokinetic characteristics of ASK120067 and CCB4580030 after the single oral administration of ASK120067 in fast and after a high-fat meal in healthy Chinese subjects, and to evaluate the effect of food on the bioavailability of ASK120067.To evaluate the safety of ASK120067 tablets administered orally in fast and fed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Take ASK120067 tablets orally in first day at 160 mg in fast condition.
Take ASK120067 tablets orally in first day at 160 mg in fed condition.
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Cmax
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out maximum concentration
Time frame: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
AUC
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out area under the plasma concentration-time curve
Time frame: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
Tmax
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out time to reach maximum concentration
Time frame: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
t1/2
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out apparent end elimination half-life
Time frame: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
CL/F
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out apparent clearance
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Time frame: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
Vd/F
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out apparent volume of distribution
Time frame: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
λz
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out apparent terminal elimination rate constant
Time frame: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
Incidence and Severity of Treatment-Emergent Adverse Events
Assessed by number and severity of adverse events as recorded on the case report form.
Time frame: Adverse events will be collected from baseline until 12 days after the administration and the follow-up period