This study was to evaluate the pharmacokinetics and safety of SHR6390 at doses of 100 mg, 125 mg, and 150 mg after process modification in Chinese healthy volunteers. A single oral dose of SHR6390 was given to each group, including 100 mg, 125mg and 150mg of SHR6390.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
SHR6390 at a single oral dose of 100 mg.
SHR6390 at a single oral dose of 125 mg.
SHR6390 at a single oral dose of 150 mg.
Phase I Clinical Research Center
Qingdao, Shandong, China
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Time frame: 12 days
Area under the plasma concentration versus time curve (AUC)0-t
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Time frame: 12 days
Area under the plasma concentration versus time curve (AUC)0-∞
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Time frame: 12 days
Incidence of Treatment-Emergent Adverse Events
Collection of adverse events
Time frame: 22 days
Incidence of abnormal blood pressure
Monitor both systolic and diastolic blood pressure
Time frame: 22 days
Incidence of abnormal temperature
Monitor the temperature
Time frame: 22 days
Incidence of abnormal electrocardiogram waveform
Electrocardiogram inspection
Time frame: 22 days
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