Clinical trial NCT06622148: Bioequivalence Study of Iron Sucrose Injection in Healthy Subjects
Official title: The Bioequivalence Study of Iron Sucrose Injection in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalency
Safety Issues
Lead sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Henan (Zhengzhou) Zhonghui Cardiovascular Hospital
name: Changsha Duxact Biotechnology Co., Ltd
name: Suzhou Guochen Biotechnology Co., Ltd.
First posted: 2024-10-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

1. Aged ≥18 years, males or females;
2. 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);
3. Subjects voluntarily sign a written informed consent form.

Exclusion Criteria:

1. 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);
2. Those with a history of iron deficiency or anemia within 6 months prior to the initial administration of the investigational drug;
3. Those with a history of allergy to two or more drugs (or foods), or allergy to iron, sucrose, or iron products;
4. 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;
5. 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;
6. Those who have received any medications or supplements (including herbal remedies) within 14 days prior to the initial administration of investigational drug;
7. 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;
8. 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;
9. 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;
10. 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;
11. Those who cannot tolerate venipuncture and/or have a history of hemophobia /fear of needles;
12. 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;
13. 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;
14. 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;
15. Those who have special dietary requirements and are unable to comply with a uniform diet or have dysphagia;
16. Those who have consumed excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups, 1 cup=250 mL) every day within 3 months prior to the initial administration of the investigational drug;
17. Those who have consumed or plan to consume any caffeine-containing foods/beverages (e.g., coffee, strong tea, chocolate) or foods (e.g., sardines, animal livers)/beverages that are rich in xanthine in the 48 hours prior to the initial administration of the investigational drug;
18. Those who have consumed or plan to consume grapefruits or grapefruit-related citrus fruits (e.g., bigarades and pomelos), carambola, pawpaws and pomegranate, those who refuse to discontinue such diet during the study, or those who had strenuous exercises within 7 days prior to the initial administration of the investigational drug;
19. Those who are addicted to smoking or who have smoked no less than 5 cigarettes per day within 3 months prior to the initial administration of the investigational drug;
20. Those who are addicted to alcohol or who have frequently consumed alcohol, namely, consumed more than 14 units of alcohol every week (1 unit ≈ 200 mL of beer containing 5% alcohol, 25 mL of liquor containing 40% alcohol, or 85 mL of wine containing 12% alcohol) within 6 months prior to the initial administration of the investigational drug;
21. Those who abuse drugs or have used soft drugs (such as cannabis) within 3 months prior to the initial administration of the investigational drug, or have used hard drugs (such as morphine, methamphetamine, ketamine, Tetrahydrocannabinol (THC), methylenedioxymethamphetamine (MDMA)) within 1 year prior to the first use of the investigational drug;
22. Those with clinically significant abnormalities in vital signs, physical examination, 12-lead electrocardiogram, or laboratory tests as determined by the investigator, and those judged by the investigator to have increased safety risks if they continue to participate in the study;
23. Those who fail the alcohol test or are positive in the drug abuse screening upon admission;
24. Those who are unable to participate in the study due to their own reasons;
25. Those who are deemed unsuitable for participation in the study by the investigator.

Primary outcomes:
measure: Pharmacokinetic parameter of total iron and transferrin-bound iron: ΔCmax
timeFrame: 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.
measure: Pharmacokinetic parameter of total iron and transferrin-bound iron: ΔAUC0-t
timeFrame: 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.
measure: Pharmacokinetic parameter of total iron and transferrin-bound iron: ΔAUC0-∞
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan (Zhengzhou) Zhonghui Cardiovascular Hospital
state: Henan
Study officials:
affiliation: Sichuan Huiyu Pharmaceutical Co., Ltd
name: Chun Wan
role: STUDY_DIRECTOR
References: