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This study was divided into two parts. The aim of this study is to investigate the bioequivalence of INS062 injection andNovoRapid ® in healthy subjects(Part I), and to investigate the pharmacokinetics and pharmacodynamics of single dose of HR20014 injection and BIAsp 30 in healthy subjects(Part II).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INS062 | Experimental |
| |
| NovoRapid ® | Active Comparator |
| |
| HR20014 | Experimental |
| |
| BIAsp 30 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INS062 injection | Drug | Part I: A single dose of 1.2noml/kg is administered. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (Part I) | Linear Up Log Down | 0 to 10 hours after dosing |
| Maximum concentration(Part I) | Observed value | 0 to 10 hours after dosing |
| Area under the Glucose Infusion Rate (GIR) - time curve (Part I) | Based on smoothed data | 0 to 10 hours after dosing |
| Maximum GIR (Part I) | Based on smoothed data | 0 to 10 hours after dosing |
| Area under the Glucose Infusion Rate (GIR) - time curve (Part II) | Based on smoothed data | 0h to 24 hours after dosing |
| Maximum GIR(Part II) | Based on smoothed data | 0 to 24 hours after dosing |
| Time to maximum GIR (Part II) | Based on smoothed data | 0 to 24 hours after dosing |
| Area under the concentration-time curve (Part II) | Linear Up Log Down | 0 to 120 hours after dosing |
| Maximum concentration(Part II) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum concentration (Part I) | Observed value | 0 to 10 hours after dosing |
| Terminal half-life (Part I) | Terminal half-life of insulin aspart |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Feng | Contact | +86-0518-82342973 | sheng.feng@hengrui.com | |
| Hong Chen | Contact | +86-0518-82342973 | hong.chen@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
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| Insulin Aspart |
| Drug |
Part I: A single dose of 0.2U/kg is administered. |
|
| HR20014 injection | Drug | Part II: Ascending single doses at three dose levels |
|
| Insulin Aspart 30 Injection | Drug | Part II: A single dosewas administered |
|
Observed value |
| 0 to 120 hours after dosing |
| Time to maximum concentration (Part II) | Observed value | 0 to 120 hours after dosing |
| 0 to 10 hours after dosing |
| Time to maximum GIR (Part I) | Based on smoothed data | 0 to 10 hours after dosing |
| Incidence of anti-drug antibody (ADA)(Part I) | Incidence of ADA for insulin aspart | from 0 hour after dosing to 3-14 days after the last dose |
| Incidence and severity of adverse events (AEs)(Part I) | The safety of test drug will be assessed | from screening to 3-14 days after the last dose |
| Incidence of anti-drug antibody (ADA)(Part II) | from 0 hour to 7-21 days after the last dose |
| Incidence and severity of adverse events (AEs)(Part II) | The safety of test drug will be assessed | from screening to 7-21 days after the last dose |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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