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NCT07768111
Clinical Study on Drug Interactions of Flonoltinib Maleate Tablets
Conditions: Drug Interaction Research
Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 40
Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd
Location: The Second Affiliated Hospital of Anhui Medical University Hefei Anhui
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 Criteria
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
Source: ClinicalTrials.gov (NCT07768111). StuddyBuddy aggregates publicly available trial information.