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Not yet recruitingNCT07768111Updated Aug 19, 2026

Clinical Study on Drug Interactions of Flonoltinib Maleate Tablets

A Phase 1 interventional study of 75mg Flonoltinib and 100mg Flonoltinib in Drug Interaction Research, sponsored by Chengdu Zenitar Biomedical Technology Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Chengdu Zenitar Biomedical Technology Co., Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

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.

02

Conditions studied

  • Drug Interaction Research

Keywords

  • FM
03

In context

Lead sponsor

Chengdu Zenitar Biomedical Technology Co., Ltd is the lead sponsor of 23 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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 form, and be able to complete the entire trial process according to the trial requirements.

Exclusion criteria

Exclusion Criteria:

  1. Screening period examination: Fridericia formula (=QT/(RR \^ 0.33)) corrected QT interval (QTcF)>450 milliseconds
  2. ,HBeAg, antibody, treponema pallidum antibody or 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
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Part A

    Drug: 75mg Flonoltinib

  • Experimental
    Part B

    Drug: 100mg Flonoltinib

Interventions

  • Day 1 and Day 12 : 75mg Flonoltinib on an empty stomach in the morning

  • Day 1 and Day 19 : 100mg Flonoltinib on an empty stomach in the morning

06

What researchers measure

Primary outcomes

  1. Cmax

    Time frame: Until 144hours

  2. Tmax

    Time frame: Until 144hours

  3. AUC0-t

    Time frame: Until 144hours

  4. t1/2

    Time frame: Until 144hours

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07768111
Responsible party
Sponsor
First posted
Aug 17, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
Dec 30, 2026 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Aug 19, 2026

Study contacts

Wang Fangmei
Contact
fangmei.wang@zenitar.cn
+8613808086495

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Flonoltinib

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