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NOT YET RECRUITING
NCT07768111
PHASE1

Clinical Study on Drug Interactions of Flonoltinib Maleate Tablets

Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-10-30

Completion Date

2027-01-31

Last Updated

2026-08-17

Healthy Volunteers

Yes

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

Locations (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China