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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-004283-31 | EudraCT Number |
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This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of the phase 3a formulation of liraglutide (formulation 4) and the liraglutide formulation planned for phase 3b trials (final formulation 4).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation 4 | Experimental |
| |
| Final formulation 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | Two single doses of 0.72 mg liraglutide administered subcutaneously on two different dosing occasions separated by a wash-out period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (0-t) | ||
| Cmax, maximum concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (0-infinity) | ||
| Relative bioavailability | ||
| Time to reach maximum (tmax) |
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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 |
|---|---|---|---|---|---|---|
| Lund | 221 85 | Sweden |
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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 |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| Terminal elimination half life (t½) |
| Terminal elimination rate constant |
| Adverse events |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |