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This trial is conducted in Europe. The aim of this trial is to compare two formulations of biphasic insulin aspart 70 and characterise the pharmacokinetics of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy male subjects.
Each subject participated in three treatment periods, and were randomly assigned to each of the six treatment sequences in varying order
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIAsp 70 clinical trial formulation | Experimental |
| |
| BIAsp 70 final formulation | Experimental |
| |
| BIAsp 50 final formulation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart 70 | Drug | A single dose administrated subcutaneously (s.c., under the skin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the insulin aspart curve in the interval from 0-24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax, maximum insulin aspart concentration | ||
| tmax, the time to maximum insulin aspart concentration | ||
| t½, terminal half-life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Leeds | LS2 9NG | United Kingdom |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| 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 |
|---|---|
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
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| biphasic insulin aspart 70 | Drug | A single dose administrated subcutaneously (s.c., under the skin) |
|
| biphasic insulin aspart 50 | Drug | A single dose administrated subcutaneously (s.c., under the skin) |
|
| Cmin, minimum glucose concentration |
| tmin, time to minimum concentration |