This study is a single center, open label, fixed sequence drug interaction study to evaluate the effects of CYP3A4 inhibitor itraconazole and CYP3A4 inducer rifampicin on the pharmacokinetic characteristics of a single oral dose of flonotinib maleate tablets.
This trial includes screening period, baseline period, medication observation period, and follow-up period, totaling approximately 3 months.
Chinese healthy adult , aged 18-45 years old
During the screening period, participants male weight >=50.0 kg, female weight >=45.0 kg and having a body mass index (BMI) between 19.0 and 26.0 kg/m²
Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the entire trial process according to the trial requirements.
Screening period electrocardiogram examination: Fridericia formula (QTcF=QT/(RR ^ 0.33)) corrected QT interval (QTcF)>450 milliseconds
HBsAg,HBeAg, hepatitis C antibody, treponema pallidum antibody or HIV Ag/Ab combined test
Individuals with a history of drug abuse or drug use, or positive urine drug abuse screening results
Individuals who have consumed any food or beverage containing alcohol, grapefruit juice/grapefruit juice, or methylxanthine (such as coffee, tea, cola, chocolate, functional drinks) within 48 hours prior to check-in
Parallel
75mg Flonoltinib
DrugDay 1 and Day 12 : 75mg Flonoltinib on an empty stomach in the morning
100mg Flonoltinib
DrugDay 1 and Day 19 : 100mg Flonoltinib on an empty stomach in the morning
Cmax
Tmax
AUC0-t
t1/2
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This trial is not recruiting at the moment. You can still explore other options:
