The purpose of this study is to estimate the effect of rifampicin or itraconazole on the single dose PK of ensartinib.
Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the range of 19 ~ 26kg /m2;
Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;
The subjects should took effective contraceptive measures voluntarily from informed consent until 3 months after Study Completion；
Able to comprehend and willing to sign an informed consent form.
Those with a history of chronic systemic or serious diseases such as cardiovascular, liver, kidney, lung, gastrointestinal, nervous, musculoskeletal, hematopoietic or metabolic diseases, especially surgical conditions or conditions that may affect drug absorption, distribution, metabolism and excretion；
Family history or presence of long QTc syndrome; History or presence of an abnormal ECG；
Hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody or human immunodeficiency virus antigen/antibody (HIV-Ag/Ab) is positive；
Use of any medications (prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products, moderate or strong CYP3A inhibitors or inducers, etc) within 14 days prior to the first administration；
Crossover
Ensartinib
Drug225 mg oral dose on day 1 in period 1 and on day 18 in period 2
Rifampicin
Drug600 mg QD from day 9 to day 22 in period 2
Itraconazole
Drug200 mg QD from day 9 to day 19 in period 2
Ensartinib
Drug100 mg oral dose on day 1 in period 1 and on day 12 in period 2
Plasma AUC0-t for Ensartinib Given Alone and With Rifampicin
AUC0-t is the plasma area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast).
Plasma AUC0-t for Ensartinib Given Alone and With Itraconazole
AUC0-t is the plasma area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast).
Plasma AUC0-∞ for Ensartinib Given Alone and With Rifampicin
AUC0-∞ is the plasma area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Plasma AUC0-∞ for Ensartinib Given Alone and With Itraconazole
AUC0-∞ is the plasma area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
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