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| Name | Class |
|---|---|
| Henan (Zhengzhou) Zhonghui Cardiovascular Hospital | UNKNOWN |
| Changsha Duxact Biotechnology Co., Ltd | UNKNOWN |
| Suzhou Guochen Biotechnology Co., Ltd. | UNKNOWN |
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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: VenoferĀ®, 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I - Receive test product first and then reference product | Experimental |
| |
| Group II - Receive reference product first and then test product | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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, VenoferĀ®, 100 mg iron/5 mL, held by AMERICAN REGENT, INC.) . |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter of total iron and transferrin-bound iron: ĪCmax | ĪCmax 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: ĪAUC0-t | ĪAUC0-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: ĪAUC0-ā | ĪAUC0-ā 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chun Wan | Sichuan Huiyu Pharmaceutical Co., Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan (Zhengzhou) Zhonghui Cardiovascular Hospital | Zhengzhou | Henan | China |
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|
| 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, VenoferĀ®, 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). |
|
| ID | Term |
|---|---|
| D000077605 | Ferric Oxide, Saccharated |
| D036881 | Long-Term Synaptic Depression |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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