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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005513-12 | EudraCT Number | ||
| U1111-1151-5077 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this trial is to investigate the influence of omeprazole on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Experimental |
| |
| Semaglutide + Omeprazole | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | All subjects will be treated for 10 consecutive days including dose escalation, with 5 days on 5 mg oral semaglutide followed by 5 days on 10 mg oral semaglutide. |
| 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 |
|---|---|---|
| Area under the SNAC plasma concentration time curve | From time 0 to 24 hours after the 10th daily dose | |
| Number of hypoglycaemic episodes | From first dosing (Day 1) to completion of the follow-up visit (Day 43 (± 2 days)) |
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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 |
|---|---|---|---|
| 29897249 | Result | Baekdal TA, Breitschaft A, Navarria A, Hansen CW. A randomized study investigating the effect of omeprazole on the pharmacokinetics of oral semaglutide. Expert Opin Drug Metab Toxicol. 2018 Aug;14(8):869-877. doi: 10.1080/17425255.2018.1488965. Epub 2018 Jun 30. | |
| 33969456 | Derived | 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. |
| 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 |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Omeprazole | Drug | Will be given daily with oral semaglutide. |
|
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |