The purpose of this study is to evaluate the drug-drug interaction of SH229 tablets and Daclatasvir dihydrochloride tablets. The study also evaluates the pharmacokinetics and tolerability of co-administration of SH229 tablets and Daclatasvir dihydrochloride tablets in healthy subjects. This study provides evidence for the designing of following clinical trial protocols.
A total of 28 evaluable healthy subjects will be enrolled in this study. The dose of SH229 is 600 mg. The dose of Daclatasvir dihydrochloride is 60 mg.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Phase I Clinical Trial Unit, The First Hospital of Jilin University
Changchun, Jilin, China
Incidence of adverse events
Cohort A and Cohort B \[Safety and tolerability\]
Time frame: Up to 1 month after last dose
Tmax, ss
Time of maximum observed concentration; safety and validity criteria
Time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
Cmax, ss
Maximum observed concentration; safety and validity criteria
Time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
Cmin, ss
Minimum observed concentration; safety and validity criteria
Time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
t1/2, ss
Elimination half-life; safety and validity criteria
Time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
AUC0-24, ss
Area under the concentration-time curve (AUC) from time 0 to 24 hours; safety and validity criteria
Time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
AUC0-72, ss
Area under the concentration-time curve (AUC) from time 0 to 72 hours; safety and validity criteria
Time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
AUC0-∞, ss
Area under the concentration-time curve (AUC) from time 0 to infinity; safety and validity criteria
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tablet, oral, 60 mg once daily for day 1 to day 14
Time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
CL/F ss
Apparent clearance; safety and validity criteria
Time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
DF
Degree of fluctuation; safety and validity criteria
Time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose