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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-005948-68 | 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 at pH 8.15 (formulation 4) and liraglutide at pH 7.7 (formulation 3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation 3 | Experimental |
| |
| Formulation 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | One single dose of 6.25 mg/mL administered subcutaneously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (0-t) | ||
| Cmax, maximum concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve | ||
| tmax, time to reach Cmax | ||
| 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 |
|---|---|---|---|---|---|---|
| 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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| liraglutide |
| Drug |
One single dose of 6.0 mg/mL administered subcutaneously |
|
| Terminal elimination rate constant |
| Adverse events |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |