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| Name | Class |
|---|---|
| BrightGene Pharmaceutical Co., Ltd. | UNKNOWN |
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This is a study to evaluate the bioequivalence of a single subcutaneous injection of BGM0504 multi-dose pen (experimental formula T1) and BGM0504 single-dose pen (experimental formula T2) with BGM0504 single-dose pen (reference formula R).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Experimental |
| |
| Group C | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGM0504 Injection multi-dose pen | Drug | 5 mg, single subcutaneous injection in the abdominal region |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Peak Plasma Concentration (Cmax) | 0 to 672 hours |
| Area under the plasma concentration versus time curve (AUC)0-t | Area under the plasma concentration versus time curve (AUC)0-t | 0 to 672 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Monitor all the adverse event | Monitor all the adverse event was assessed by the investigator. | 29 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou First People's Hospital | Recruiting | Hangzhou | Zhejiang | 310006 | China |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C058388 | penclomedine |
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| BGM0504 Injection single-dose pen | Drug | 5 mg, single subcutaneous injection in the abdominal region |
|
| BGM0504 Injection single-dose pen | Drug | 5 mg, single subcutaneous injection in the abdominal region |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |