Bioequivalence Study of Iron Sucrose Injection in Healthy Subjects

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

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).

Sponsors & Collaborators

• Henan (Zhengzhou) Zhonghui Cardiovascular Hospital

  collaborator UNKNOWN

• Changsha Duxact Biotechnology Co., Ltd

  collaborator UNKNOWN

• Suzhou Guochen Biotechnology Co., Ltd.

  collaborator UNKNOWN

• Sichuan Huiyu Pharmaceutical Co., Ltd

  lead INDUSTRY

Principal Investigators

• Chun Wan · Sichuan Huiyu Pharmaceutical Co., Ltd

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-06-25

Primary Completion

2024-07-26

Completion

2024-07-26

Countries

• China

Study Locations