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Not Yet Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07768111). StuddyBuddy aggregates publicly available trial information.