Healthy Adult Subjects Clinical Trial
Official title:
Pharmacokinetic Evaluation Study of Healthy Chinese Volunteers After Oral Administration of SHR1459 Tablets in Old and New Formulation
The primary objective of the study is to evaluate the pharmacokinetics of healthy Chinese volunteers after oral administration of SHR1459 tablets in new and old formulations. The secondary objective of the study is to evaluate the safety after single dose of SHR1459 orally in healthy Chinese subjects.
The PK parameters (AUC0-t, AUC0-inf, Cmax, Tmax, T1/2z, CL/F and Vz/F etc.) will be calculated to evaluate the pharmacokinetics of healthy Chinese volunteers after oral administration of SHR1459 tablets in new and old formulations. During the study, the safety will be assessed by vital signs, physical examination, laboratory examination (hematology, blood biochemistry, urinalysis, coagulation examination), 12-lead electrocardiogram. The incidence and severity degree of adverse events and severe adverse events will be evaluated based on CTCAE 5.0. ;
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