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Clinical Study on Drug Interactions of Flonoltinib Maleate Tablets

NCT07768111 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-19

No results posted yet for this 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.

Conditions

  • Drug Interaction Research

Interventions

DRUG

75mg Flonoltinib

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

DRUG

100mg Flonoltinib

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

Sponsors & Collaborators

  • Chengdu Zenitar Biomedical Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-10-30
Primary Completion
2026-12-30
Completion
2027-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07768111 on ClinicalTrials.gov