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This trial is conducted in Oceania. The aim of this trial is to test for bioequivalence between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned Phase 3 formulation at pH 7.7.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pH 7.7 | Experimental |
| |
| pH 7.9 | Experimental |
| |
| pH 8.15 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | One single dose of 0.75 mg administered on three different dosing occasions with a 14-day wash-out period between each dosing. Injected subtaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Curve (0-t) | ||
| Cmax, maximum concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (0-infinity) | ||
| 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 |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Adelaide | 5000 | Australia |
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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 rate constant |
| Adverse events |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |