Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
NCT Number: NCT04423601
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.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Guangzhou, Guangdong, 510120, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
single oral dose of SHR6390 or co-administered with itraconazole.
200 mg itraconazole was administered in the morning.
Time frame: through study completion, an average of 32 days
Peak Plasma Concentration (Cmax) of SHR6390
Time frame: through study completion, an average of 32 days
Area under the plasma concentration versus time curve (AUC) of SHR6390
Time frame: through study completion, an average of 32 days
Time of maximum observed concentration (Tmax) of SHR6390
Time frame: through study completion, an average of 32 days
Half time (T1/2) of SHR6390
Time frame: through study completion, an average of 32 days
Total body clearance for extravascular administration (CL/F) of SHR6390
Jiangsu HengRui Medicine Co., Ltd.
Industry
A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Chinese Adult Subjects.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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