75mg Flonoltinib: Day 1 and Day 12 : 75mg Flonoltinib on an empty stomach in the morning
100mg Flonoltinib: Day 1 and Day 19 : 100mg Flonoltinib on an empty stomach in the morning
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Cmax — Until 144hours
Tmax — Until 144hours
AUC0-t — Until 144hours
t1/2 — Until 144hours
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital of Anhui Medical University
Hefei
Anhui
More Chengdu Zenitar Biomedical Technology Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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