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Bioequivalence Study of Iron Sucrose Injection in Healthy Participants

NCT06674486 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-03-24

No results posted yet for this study

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 Vifor France? \[Question 2\] 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 Vifor France? 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 Vifor France).

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 Vifor France) . 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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-22
Primary Completion
2024-12-18
Completion
2025-03-14

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06674486 on ClinicalTrials.gov