Bioequivalence Study of Iron Sucrose Injection in Healthy Subjects

NCT06622148 | Completed Phase 1

• 1 other identifier: DUXACT-2308040
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic parameter of total iron and transferrin-bound iron: ΔCmax

  ΔCmax is the maximum difference between the concentrations of total iron and transferrin-bound iron.

  24 hours, 12 hours and 0 hour before administration, 2, 6, 8, 10, 15, 30 and 45 minutes, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, 48, 72, 96 and 120 hours.

• Pharmacokinetic parameter of total iron and transferrin-bound iron: ΔAUC0-t

  ΔAUC0-t is the difference in the area under the concentration-time curve from zero to time point t of the last measurable concentration between total iron and transferrin-bound iron.

  24 hours, 12 hours and 0 hour before administration, 2, 6, 8, 10, 15, 30 and 45 minutes, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, 48, 72, 96 and 120 hours.

• Pharmacokinetic parameter of total iron and transferrin-bound iron: ΔAUC0-∞

  ΔAUC0-∞ is the difference in the area under the concentration-time curve from zero to infinity between total iron and transferrin-bound iron.

  24 hours, 12 hours and 0 hour before administration, 2, 6, 8, 10, 15, 30 and 45 minutes, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, 48, 72, 96 and 120 hours.

Study Arms (2)

Group I - Receive test product first and then reference product

EXPERIMENTAL

Drug: Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) and Iron Sucrose injection (Reference product, Venofer)

Group II - Receive reference product first and then test product

EXPERIMENTAL

Drug: Iron Sucrose injection (Reference product, Venofer) and Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd)

Interventions

Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) and Iron Sucrose injection (Reference product, Venofer) DRUG

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.) .

Group I - Receive test product first and then reference product

Iron Sucrose injection (Reference product, Venofer) and Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) DRUG

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).

Group II - Receive reference product first and then test product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years, males or females;
• Body weight ≥ 50.0 kg (male subjects) or ≥ 45.0 kg (female subjects), and Body Mass Index (BMI) within 19-26 kg/m2 (both inclusive);
• Subjects voluntarily sign a written informed consent form.

You may not qualify if:

• Those who have a history of or currently have clinically serious diseases, including circulatory, endocrine, nervous, digestive, and respiratory, hematology, immunology, psychiatry and metabolic disorders or abnormalities or any other diseases that can interfere with the study results (e.g., non-iron deficiency anemia, history of severe asthma, hepatic or renal insufficiency);
• Those with a history of iron deficiency or anemia within 6 months prior to the initial administration of the investigational drug;
• Those with a history of allergy to two or more drugs (or foods), or allergy to iron, sucrose, or iron products;
• Those who have undergone surgery within 28 days prior to the initial administration of the investigational drug, or who plan to undergo surgery during the study period;
• Those who have been vaccinated within 28 days prior to the initial administration of the investigational drug, or who plan to be vaccinated during the study period;
• Those who have received any medications or supplements (including herbal remedies) within 14 days prior to the initial administration of investigational drug;
• Those who have used any iron supplements or iron-containing herbs or nutritional supplements within 3 months prior to the initial administration of the investigational drug;
• Those who have used any drugs that inhibit or induce hepatic drug metabolism (e.g., inducers-barbiturates, carbamazepine, phenytoin and rifampicin; inhibitors-selective serotonin reuptake inhibitors (SSRIs), cimetidine, cyclosporine, macrolides, verapamil, quinolones, pyrrole-containing antifungals and Human Immunodeficiency Virus (HIV) protease inhibitors) within 30 days prior to the initial administration of the investigational drug;
• Those who have used any investigational medicinal product or been enrolled in any clinical studies of drugs/medical devices within 3 months prior to the initial administration of the investigational drug;
• Those who have donated blood or had a blood loss volume of \>400 mL within 3 months before the initial administration of the investigational drug;
• Those who cannot tolerate venipuncture and/or have a history of hemophobia /fear of needles;
• Those who have used oral contraceptives within 30 days before the initial administration of the investigational drug, or who have received long-acting estrogens or progesterone injections or implants within 6 months before the initial administration of the investigational drug;
• Those (females) who have had unprotected sex within 14 days prior to the initial administration of the investigational drug, or females who are pregnant or breastfeeding;
• Subjects and their partners who cannot take at least one non-medication contraceptive measures throughout the study period, or those who plan to bear a child, or donate egg or sperm from signing the Informed Consent Form (ICF) to 3 months after the end of the study;
• Those who have special dietary requirements and are unable to comply with a uniform diet or have dysphagia;

Sponsors & Collaborators

• Sichuan Huiyu Pharmaceutical Co., Ltd: lead
• Henan (Zhengzhou) Zhonghui Cardiovascular Hospital: collaborator
• Changsha Duxact Biotechnology Co., Ltd: collaborator
• Suzhou Guochen Biotechnology Co., Ltd.: collaborator

Study Sites (1)

Henan (Zhengzhou) Zhonghui Cardiovascular Hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Interventions

Ferric Oxide, Saccharated; Long-Term Synaptic Depression

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Chun Wan

  Sichuan Huiyu Pharmaceutical Co., Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 1, 2024
• Study Start: June 25, 2024
• Primary Completion: July 26, 2024
• Study Completion: July 26, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)