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Clinical Study on Drug Interactions of Flonoltinib Maleate Tablets
Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd
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
Conditions
Interventions
75mg Flonoltinib
Day 1 and Day 12 : 75mg Flonoltinib on an empty stomach in the morning
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