NCT05041920

A Drug-drug Interaction Study of Famitinib Malate With a Proton Pump Inhibitor in Healthy Adult Subjects

A Single-centre, Single-arm, Open-label and Fixed-sequence Study to Evaluate the Effect of Omeprazole on Pharmacokinetics of Famitinib Malate in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to evaluate the effect of omeprazole on the pharmacokinetics of famitinib malate in healthy adult subjects. The secondary objective is to evaluate the safety after famitinib malate alone or combined administration with omeprazole in healthy adult subjects.

Conditions

• Tumor

Interventions

Type	Name	Description
DRUG	famitinib、omeprazole	famitinib malate, 25 mg on study day 1; omeprazole, 40 mg, qd on study day 10-14, 16-22; famotine malate together with omeprazole, on study day 15.

Timeline

• Start date: 2021-09-07
• Primary completion: 2021-10-06
• Completion: 2021-10-27
• First posted: 2021-09-13
• Last updated: 2023-05-24

Locations

1 site across 1 country: China