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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000979-87 | EudraCT Number | ||
| U1111-1154-0535 | 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 NNC0123-0000-0338 in a tablet formulation in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eating meal immediately after dosing | Experimental |
| |
| Eating meal 30 min after dosing | Experimental |
| |
| Eating meal 1 hour after dosing | Experimental |
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| Eating meal 6 hour after dosing | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin 338 (GIPET I) | Drug | Each subject will be randomly allocated to a fixed treatment sequence of four single-dose administrations of oral insulin 338 in a GIPET® I tablet, administered on four separate dosing visits. The subjects will be dosed in the morning in the fasting state prior to four different post-dose fasting periods. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin 338 concentration-time curve | From a 0-288 hours NNC0123-0000-0338 serum concentration-time-curve based on 41 sampling time points |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin 338 concentration-time curve | From 0 to 288 hours after a single dose (SD) | |
| Maximum observed serum insulin 338 concentration | From 0 to 288 hours after a single dose (SD) |
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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 | Neuss | 41460 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31093929 | Result | Halberg IB, Lyby K, Wassermann K, Heise T, Plum-Morschel L, Zijlstra E. The Effect of Food Intake on the Pharmacokinetics of Oral Basal Insulin: A Randomised Crossover Trial in Healthy Male Subjects. Clin Pharmacokinet. 2019 Nov;58(11):1497-1504. doi: 10.1007/s40262-019-00772-2. |
| 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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| Area under the plasma capric acid concentration-time curve | From 0 to 24 hours after a single dose |
| Maximum observed plasma capric acid concentration | From 0 to 24 hours after a single dose |