NCT05046808

Pharmacokinetics Study of Famitinib Malate Capsules in Healthy Subjects

A Single-center, Randomized, Open-label Pharmacokinetic Study of Famitinib Malate Capsules in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, randomized, open-label study to compare the pharmacokinetic profiles of Famitinib and its metabolite SHR116637 at different doses/specifications.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Famitinib Malate Capsules	Famitinib Malate Capsules 10mg single dose
DRUG	Famitinib Malate Capsules	Famitinib Malate Capsules 15mg single dose
DRUG	Famitinib Malate Capsules	Famitinib Malate Capsules 20mg single dose
DRUG	Famitinib Malate Capsules	Famitinib Malate Capsules 10mg\*2 single dose
DRUG	Famitinib Malate Capsules	Famitinib Malate Capsules 25mg single dose

Timeline

• Start date: 2021-09-23
• Primary completion: 2021-10-08
• Completion: 2021-11-22
• First posted: 2021-09-16
• Last updated: 2023-06-08

Locations

1 site across 1 country: China