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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1266-4254 | Other Identifier | World Health Organization (WHO) | |
| 2022-500007-52-00 | Other Identifier | EU CT number |
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This study will test how the active substances semaglutide and dapagliflozin act in the body (in terms of their levels in the blood), when they are taken in the form of a combination preparation (a tablet with a fixed dose combination) compared to when oral semaglutide and dapagliflozin are given alone.The study will consist of 2 parts. Part 1 will compare semaglutide to the fixed dose combination tablet (semaglutide/dapagliflozin) and part 2 will compare dapagliflozin to the fixed dose combination tablet (semaglutide/dapagliflozin). Participants will take part in either part 1 or part 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 sequence A | Experimental | Semaglutide followed by Semaglutide/dapagliflozin |
|
| Part 1 sequence B | Experimental | Semaglutide/dapagliflozin followed by Semaglutide |
|
| Part 2 sequence A | Experimental | Dapagliflozin followed by Semaglutide/dapagliflozin |
|
| Part 2 sequence B | Experimental | Semaglutide/dapagliflozin followed by dapagliflozin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Tablet given orally |
| |
| Dapagliflozin |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24h,sema,ss: area under the semaglutide plasma concentration-time curve during a dosing interval (0 to 24 hours) at steady state | measured in h*nmol/L | From 0 to 24 hours on day 49 and 84 in Part 1 |
| AUC0-24h,dapa,ss: area under the dapagliflozin plasma concentration-time curve during a dosing interval (0 to 24 hours) at steady state | measured inh*ng/mL | From 0 to 24 hours on day 49 and 98 in Part 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,sema,ss: maximum observed semaglutide plasma concentration during a dosing interval (0 to 24 hours) at steady state) | measured in nmol/L | From 0 to 24 hours on day 49 and 84 in Part 1 |
| Cmax,dapa,ss: maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state |
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Inclusion Criteria:
Exclusion Criteria:
Participation (i.e., signed informed consent) in any other interventional, clinical study within 30 days (or 5 half-lifes of the investigational medicinal product, whichever is longer) before randomisation.
Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly-effective contraceptive method.
Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Use of tobacco and nicotine products, defined as any of the below:
Blood donation, plasma donation or blood draw, defined as any of the below:
History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.
Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Berlin | Brandenburg | 14050 | Germany | ||
| Parexel International GmbH |
"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
| C529054 | dapagliflozin |
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| Drug |
Tablet given orally |
|
| Semaglutide/dapagliflozin | Drug | Tablet given orally |
|
measured in ng/mL |
| From 0 to 24 hours on day 49 and 98 in Part 2 |
| tmax,sema,ss: time to maximum observed semaglutide plasma concentration during a dosing interval (0 to 24) at steady state | measured in hours | From 0 to 24 hours on day 49 and 84 in Part 1 |
| tmax,dapa,ss: time to maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state | measured in hours | From 0 to 24 hours on day 49 and 98 in Part 2 |
| Berlin |
| 14050 |
| Germany |