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This trial is conducted in Japan. The aim of this trial is to investigate the pharmacokinetics of biphasic insulin aspart 50 (NN-X14Mix50) and biphasic insulin aspart 70 (NN-X14Mix70) in Japanese healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment period 1 | Experimental |
| |
| Treatment period 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart 50 | Drug | A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 70) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax, maximum insulin aspart concentration | ||
| tmax, time to maximum insulin aspart concentration | ||
| t½, terminal elimination 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 | Tokyo | 1000005 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Irie S, Furuie H, Matsuguma K, Matsumura Y. Pharmacokinetics and pharmacodynamics of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy Japanese subjects. Diabetologia 2006; 49 (Suppl 1): 612 | ||
| Result | Irie S, Matsumura Y, Furuie H, Matsuguma K. Comparison of the pharmacokinetic and pharmacodynamic properties of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy Japanese. Diabetic Medicine 2006; 23 (Suppl 4): 331 (P915) |
| 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 of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days |
|
| Mean residence time (MRT) |
| Area under the curve from time 0 to infinity (0-∞) |
| Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 50) |
| Adverse events |