NCT05336279

Bioequivalence Study of Famitinib Malate in Healthy Volunteers Under Fasting Condition

A Single-center, Single-dose, Randomized, Open-label, Two-cycle, Crossover Study of Bioequivalence of Famitinib Malate Capsules of Different Specifications Taken Orally in Healthy Subjects Under Fasting Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study is a single-centre, randomized, open, 2-period, 2-sequence crossover design clinical trial. It is planned to enroll 28 healthy subjects. Subjects will receive famitinib malate on Day1 and Day13.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	famitinib malate T(5 mg*4)、famitinib malate R(20 mg)	TR Group: famitinib malate T on day 1, famitinib malate R on day 13.
DRUG	famitinib malate T(5 mg*4)、famitinib malate R(20 mg)	RT Group: famitinib malate R on day 1, famitinib malate T on day 13.

Timeline

• Start date: 2022-05-11
• Primary completion: 2022-05-27
• Completion: 2022-06-20
• First posted: 2022-04-20
• Last updated: 2023-05-18

Locations

1 site across 1 country: China