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The aim of this trial is to demonstrate bioequivalence of Wosulin R to Actrapid with regard to its total and to its maximum serum insulin concentrations.
The purpose of this study is the comparative evaluation of the Pharmacodynamics and Pharmacokinetics of two recombinant regular human insulin injections administered intravenously in healthy volunteers under the conditions of euglycemic clamp.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wosulin R | Experimental | Wosulin R, Regular insulin for injection (Recombinant Human Insulin) (100 IU/mL)in vials 10.0 ml |
|
| Actrapid | Active Comparator | Actrapid, Regular insulin for injection (Recombinant Human Insulin) (100 IU/mL)in vials 10.0 ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wosulin R | Biological | Total dose per subject will be 0.3 IU/Kg given IV over 5 hrs. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The area under the GIR-time curve at steady state from 240 to 300 minutes (AUCGIR-SS) | Visit 2 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| PD Endpoints: Area under the GIR-time curve from 0 to 7 hours, GlR at steady state. PK Endpoints: AUCINS-SS, AUCINS0-7h, CLtot, VSS, t1/2 ,Terminal rate constant Safety Endpoints: AE, Lab assessments, Vital signs, Phy Exam, ECG & Hypoglycemia. | Visit 2 , 3 and 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcus Hompesch, MD | Profil Institute of Clinical Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institute for Clinical Research Inc. | Chula Vista | California | 91911 | United States |
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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 |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Actrapid |
| Biological |
Total dose per subject will be 0.3 IU/Kg given IV over 5 hrs. |
|
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |