The Safety, Tolerability Pharmacokinetic and Food Effect Study of HEC73077 in Healthy Subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
138
Single-Dose Study: Each dose of HEC73077 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight. Multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and/or multiple-dose study.
Single-Dose Study: Each dose of HEC73077 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight. Multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and/or multiple-dose study.
The First Hospital of Jilin University
Changchun, Jilin, China
Adverse Events
Incidence of adverse events
Time frame: Up to 19 days
Cmax
Maximum plasma concentration of study drugs
Time frame: Day 1-17
AUC0-∞
area under the concentration versus time curve (AUC) from time zero to infinity
Time frame: Day 1-17
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