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The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in healthy subject.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | HR011408 injection + NovoRapid® |
|
| Cohort 2 | Experimental | NovoRapid® + HR011408 injection |
|
| Cohort 3 | Experimental | HR011408 injection + NovoRapid® |
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| Cohort 4 | Experimental | NovoRapid® + HR011408 injection |
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| Cohort 5 | Experimental |
| |
| Cohort 6 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR011408 injection; NovoRapid® | Drug | HR011408 injection, administered subcutaneously in dose 1. NovoRapid®, administered subcutaneously in dose 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC0-0.5h) | Area under the concentration-time curve (AUC) | from 0 to 30 minutes after dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC0-15min) | from 0 to 15 minutes after dose administration | |
| Area under the concentration-time curve (AUC0-1h) | from 0 to 1 hour after dose administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
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Crossover Assigned to HR011408 or NovoRapid®
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| NovoRapid®;HR011408 injection | Drug | NovoRapid®, administered subcutaneously in dose 1. HR011408 injection, administered subcutaneously in dose 1. |
|
| HR011408 injection; NovoRapid® | Drug | HR011408 injection, administered subcutaneously in dose 2. NovoRapid®, administered subcutaneously in dose 2. |
|
| NovoRapid®;HR011408 injection | Drug | NovoRapid®, administered subcutaneously in dose 2. HR011408 injection, administered subcutaneously in dose 2. |
|
| HR011408 injection; NovoRapid® | Drug | HR011408 injection, administered subcutaneously in dose 3. NovoRapid®, administered subcutaneously in dose 3. |
|
| HR011408 injection; NovoRapid® | Drug | NovoRapid®, administered subcutaneously in dose 3. HR011408 injection, administered subcutaneously in dose 3. |
|
| Area under the concentration-time curve (AUC0-1.5h) | from 0 to 1.5 hours after dose administration |
| Area under the concentration-time curve (AUC0-2h) | from 0 to 2 hours after dose administration |
| Area under the concentration-time curve (AUC0-10h) | from 0 to 10 hours after dose administration |
| Area under the concentration-time curve (AUC0-inf) | from 0 to infinity after dose administration |
| Onset of appearance | First time point after dose administration when concentration reaches lower limit of quantification (LLOQ) | from 0 to 8 hours after dose administration |
| Time to 50% maximum observed concentration (time to 50% Cmax) | from 0 to 8 hours after dose administration |
| Time to maximum observed concentration (Tmax) | from 0 to 8 hours after dose administration |
| Maximum observed concentration (Cmax) | from 0 to 8 hours after dose administration |
| Elimination half-life (t1/2) | from 0 to 8 hours after dose administration |
| Area under the GIR-time curve (AUC) | Area under the GIR-time curve (AUC0-10h) | from 0 to 10 hours after dose administration |
| Time to 50% maximum observed GIR(time to 50% GIRmax) | from 0 to 10 hours after dose administration |
| Time to maximum observed GIR (GIRmax) | from 0 to 10 hours after dose administration |
| Incidence and severity of adverse events (AEs) | from Day1 to Day14 after dose administration |
| 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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