Clinical Study on Drug Interactions of Flonoltinib Maleate Tablets

A Single-Center, Open, Fixed-Sequence Clinical Drug Interaction Study Evaluating the Effects of Itraconazole or Rifampicin on the Pharmacokinetic Profile of Flonoltinib Maleate Tablets in Healthy Participants

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.

Inclusion Criteria:

1. Chinese healthy adult , aged 18-45 years old
2. 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/m^2
3. 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.

Exclusion Criteria:

1. Screening period electrocardiogram examination: Fridericia formula (QTcF=QT/(RR ^ 0.33)) corrected QT interval (QTcF)>450 milliseconds
2. HBsAg,HBeAg, hepatitis C antibody, treponema pallidum antibody or HIV Ag/Ab combined test
3. Individuals with a history of drug abuse or drug use, or positive urine drug abuse screening results
4. 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
5. Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection