NCT07193576

A Pharmacokinetic Study of the Food Effect on Flonoltinib Maleate Tablets

A Randomized, Open-Label, Two-Period, Two-Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Flonoltinib Maleate Tablets in Healthy Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A Randomized, Open-Label, Two-Period, Two-Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Flonoltinib Maleate Tablets in Healthy Subjects Under Fed Conditions

Detailed description

Primary Study Objective. To evaluate the effect of a high-fat diet on the pharmacokinetics of single-dose oral Flonoltinib Maleate tablets in healthy subjects. Secondary Study Objectives To evaluate the safety of single-dose oral administration of Flonoltinib Maleate Tablets under Fast or Fed condition in healthy subjects.

Conditions

• Heathly Subjects

Interventions

Type	Name	Description
DRUG	flunotinib	100mg

Timeline

• Start date: 2024-08-04
• Primary completion: 2024-09-11
• Completion: 2024-09-11
• First posted: 2025-09-26
• Last updated: 2025-09-26

Locations

1 site across 1 country: China