The primary objective of the study is to evaluate the effect of itraconazole on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR6390 tablets. The secondary objective of the study is to evaluate the safety of SHR6390 alone and when co-administered with itraconazole. The exploratory objective of the study is to explore the effect of SHR6390 related metabolic enzymes and transporter gene polymorphisms on the pharmacokinetics of SHR6390.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
18
single oral dose of SHR6390 or co-administered with itraconazole.
200 mg itraconazole was administered in the morning.
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Pharmacokinetics parameter: Cmax of SHR6390
Peak Plasma Concentration (Cmax) of SHR6390
Time frame: through study completion, an average of 32 days
Pharmacokinetics parameter: AUC of SHR6390
Area under the plasma concentration versus time curve (AUC) of SHR6390
Time frame: through study completion, an average of 32 days
Pharmacokinetics parameter: Tmax of SHR6390
Time of maximum observed concentration (Tmax) of SHR6390
Time frame: through study completion, an average of 32 days
Pharmacokinetics parameter: T1/2 of SHR6390
Half time (T1/2) of SHR6390
Time frame: through study completion, an average of 32 days
Pharmacokinetics parameter: CL/F of SHR6390
Total body clearance for extravascular administration (CL/F) of SHR6390
Time frame: through study completion, an average of 32 days
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