Clinical Study on Drug Interactions of Flonoltinib Maleate Tablets

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07768111

Enrollment

Registered

2026-08-17

Start date

2026-10-30

Completion date

2027-01-31

Last updated

2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Interaction Research

Keywords

Brief 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.

Interventions

DRUG75mg Flonoltinib

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

DRUG100mg Flonoltinib

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Cmax	Until 144hours
Tmax	Until 144hours
AUC0-t	Until 144hours
t1/2	Until 144hours

Countries

China

Contacts

CONTACTWang Fangmei

fangmei.wang@zenitar.cn+8613808086495

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026