Clinical Study on Drug Interactions of Flonoltinib Maleate Tablets

August 17, 2026 updated by: Chengdu Zenitar Biomedical Technology Co., Ltd

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • The Second Affiliated Hospital of Anhui Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A
Drug: 75mg Flonoltinib
Day 1 and Day 12 : 75mg Flonoltinib on an empty stomach in the morning
Experimental: Part B
Drug: 100mg Flonoltinib
Day 1 and Day 19 : 100mg Flonoltinib on an empty stomach in the morning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax
Time Frame: Until 144hours
Until 144hours
Tmax
Time Frame: Until 144hours
Until 144hours
AUC0-t
Time Frame: Until 144hours
Until 144hours
t1/2
Time Frame: Until 144hours
Until 144hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: From dosing (Day 0) through study completion (Day 29)
Incidence of Treatment-Emergent Adverse Events
From dosing (Day 0) through study completion (Day 29)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu Zenitar Biomedical Technology Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 30, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

August 5, 2026

First Submitted That Met QC Criteria

August 14, 2026

First Posted (Actual)

August 17, 2026

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FM-DDI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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