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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019653-17 | EudraCT Number | ||
| U1111-1120-6776 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing conditions for semaglutide (a long acting GLP-1 analogue) in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-dose fasting 120 mins/50 ml water | Experimental |
| |
| Post-dose fasting 60 mins/50 ml water | Experimental |
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| Post-dose fasting 30 mins/50 ml water | Experimental |
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| Post-dose fasting 15 mins/50 ml water | Experimental |
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| Post-dose fasting 120 mins/120 ml water | Experimental |
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| Post-dose fasting 60 mins/120 ml water | Experimental |
| |
| Post-dose fasting 30 mins/120 ml water | Experimental |
| |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 120 mins, no food or liquid is allowed. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC 0-24h; Area under the semaglutide concentration curve from time 0-24 hours after the 10th dosing | 0-24hrs after the 10th dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax; The maximum plasma semaglutide concentration | Post-dose at day 10 | |
| tmax; Time to maximum plasma semaglutide concentration | Post-dose at day 10 | |
| t1/2; the terminal half-life of semaglutide |
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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 | 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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| Post-dose fasting 15 mins/120 ml water |
| Experimental |
|
| semaglutide | Drug | Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 60 mins, no food or liquid is allowed. |
|
| semaglutide | Drug | Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 30 mins, no food or liquid is allowed. |
|
| semaglutide | Drug | Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 15 mins, no food or liquid is allowed. |
|
| semaglutide | Drug | Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 120 mins, no food or liquid is allowed. |
|
| semaglutide | Drug | Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 60 mins, no food or liquid is allowed. |
|
| semaglutide | Drug | Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 30 mins, no food or liquid is allowed. |
|
| semaglutide | Drug | Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 15 mins, no food or liquid is allowed. |
|
| Post-dose at day 10 |
| 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. |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| 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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