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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004707-39 | EudraCT Number | ||
| U1111-1149-8127 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to investigate the effect of food on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide, in a SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) tablet formulation with three different dosing conditions in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fed conditions | Experimental | Fasting for 10 hours overnight followed by a high-fat, high-calorie meal, after the meal dosing of the tablet with 240 mL of water and a post-dose fasting period of 4 hours |
|
| Fasting conditions | Experimental | Fasting for 10 hours overnight followed by dosing of the tablet with 240 mL of water and a post-dose fasting period of 4 hours |
|
| Reference dosing condition | Experimental | Fasting for 6 hours overnight followed by dosing of the tablet with 120 mL of water and a post-dose fasting period of 30 min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | For oral administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the semaglutide plasma concentration time curve | From time 0 to 24 hours after the 10th daily dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed semaglutide plasma concentration | 0 to 24 hours after the 10th daily dose | |
| Time to maximum observed semaglutide plasma concentration | 0 to 24 hours after the 10th daily dose | |
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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 |
|---|---|---|---|---|---|---|
| Berlin | 14050 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34080123 | Derived | Baekdal TA, Breitschaft A, Donsmark M, Maarbjerg SJ, Sondergaard FL, Borregaard J. Effect of Various Dosing Conditions on the Pharmacokinetics of Oral Semaglutide, a Human Glucagon-Like Peptide-1 Analogue in a Tablet Formulation. Diabetes Ther. 2021 Jul;12(7):1915-1927. doi: 10.1007/s13300-021-01078-y. Epub 2021 Jun 2. | |
| 33969456 |
| 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 |
|---|---|
| C000591245 | semaglutide |
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| Terminal half-life of semaglutide |
| After the 10th daily dose |
| Area under the SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) plasma concentration time curve | From time 0 to 24 hours after the 10th daily dose |
| Overgaard RV, Navarria A, Ingwersen SH, Baekdal TA, Kildemoes RJ. Clinical Pharmacokinetics of Oral Semaglutide: Analyses of Data from Clinical Pharmacology Trials. Clin Pharmacokinet. 2021 Oct;60(10):1335-1348. doi: 10.1007/s40262-021-01025-x. Epub 2021 May 10. |