Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Henan (Zhengzhou) Zhonghui Cardiovascular Hospital | UNKNOWN |
| Changsha Duxact Biotechnology Co., Ltd | UNKNOWN |
| Suzhou Guochen Biotechnology Co., Ltd. | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
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 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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 Vifor France). |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter of total iron and transferrin-bound iron: Cmax | Cmax is the maximum observed concentration of total iron and transferrin-bound iron. | 36 hours, 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, and 36 hours |
| Pharmacokinetic parameter of total iron and transferrin-bound iron: AUC0-t | AUC0-t is the area under the plasma concentration-time curve from time zero to time point t for the last measurable concentration of total iron and transferrin-bound iron. | 36 hours, 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, and 36 hours. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan (Zhengzhou) Zhonghui Cardiovascular Hospital | Zhengzhou | Henan | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 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). |
|
| 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 |
Not provided
Not provided