NCT06622148

Bioequivalence Study of Iron Sucrose Injection in Healthy Subjects

The Bioequivalence Study of Iron Sucrose Injection in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to compare the pharmacokinetic profile of the single intravenous injection of the test product and reference product in healthy subjects and to evaluate the bio-equivalence and safety of these two injections in healthy subjects. The main questions it aims to answer are: \[Question 1\] Is there significant difference in the pharmacokinetic profile between the Iron Sucrose Injection (100 mg/5 mL \[calculated by iron\]) manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd. and the Iron Sucrose Injection (trade name: Venofer®, 100 mg/5 mL \[calculated by iron\]) held by AMERICAN REGENT, INC.? \[Question 2\] Is it safe for the healthy subjects to take the test product (100 mg/5 mL \[calculated by iron\]) manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd. and the reference product held by AMERICAN REGENT, INC.? Participants will be randomly divided into group I and group II, with equal number of subjects in each group. Each subject will receive only one dose of either the test product or the reference product in each period (two-sequence crossover study).

Conditions

• Bioequivalency
• Safety Issues

Interventions

Type	Name	Description
DRUG	Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) and Iron Sucrose injection (Reference product, Venofer)	For the Group I, participants will receive a single intravenous injection of the Test Product (Iron sucrose injection, 100 mg iron/5 mL, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd). After a washout period, subjects will receive a single intravenous injection of the Reference Product (Iron sucrose injection, Venofer®, 100 mg iron/5 mL, held by AMERICAN REGENT, INC.) .
DRUG	Iron Sucrose injection (Reference product, Venofer) and Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd)	For the Group II, participants will receive a single intravenous injection of the Reference Product (Iron sucrose injection, Venofer®, 100 mg iron/5 mL, held by AMERICAN REGENT, INC.) . After a washout period, subjects will receive a single intravenous injection of the Test Product (Iron sucrose injection, 100 mg iron/5 mL, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd).

Timeline

• Start date: 2024-06-25
• Primary completion: 2024-07-26
• Completion: 2024-07-26
• First posted: 2024-10-01
• Last updated: 2024-10-08

Locations

1 site across 1 country: China