NCT04400123

A Bioequivalence Study of Famitinib Malate on Healthy Chinese Volunteers

A Single-centre, Single-dose, Randomized, Open-label and Two-cycle Crossover Bioequivalence Study of Famitinib Malate Capsules in Old and New Formulation on Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to evaluate the bioequivalence of famitinib malate capsules in new and old formulations after oral dose under fasted condition on healthy Chinese subjects. The secondary objective is to evaluate the safety after famitinib malate capsules oral dose on healthy Chinese subjects.

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
DRUG	Famitinib malate	TR group: The first period，the subjects will be administrated with Famitinib malate in new formulation, then conduct blood collection within 192h; 14 days washout；The second period，the subjects will be administrated with Famitinib malate in old formulation, then conduct blood collection within 192h. RT group: The first period，the subjects will be administrated with Famitinib malate in old formulation, then conduct blood collection within 192h; 14 days washout；The second period，the subjects will be administrated with Famitinib malate in new formulation, then conduct blood collection within 192h.

Timeline

• Start date: 2020-05-27
• Primary completion: 2020-07-18
• Completion: 2020-07-18
• First posted: 2020-05-22
• Last updated: 2021-10-22

Locations

1 site across 1 country: China