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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004202-10 | EudraCT Number | ||
| U1111-1134-6321 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0123-0000-0338 (insulin 338) in a tablet formulation with three different coatings in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coating A | Experimental | Each subject will in random order be allocated to three single-dose administrations of insulin 338 in a GIPET® I tablet with 3 different coatings, respectively, on three separate dosing visits (Visits 2, 3 and 4). Each of the three dosing days will be separated by a 3-week wash-out period (ranging from 20 to 28 days) |
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| Coating B | Experimental | Each subject will in random order be allocated to three single-dose administrations of insulin 338 in a GIPET® I tablet with 3 different coatings, respectively, on three separate dosing visits (Visits 2, 3 and 4). Each of the three dosing days will be separated by a 3-week wash-out period (ranging from 20 to 28 days) |
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| Coating C | Experimental | Each subject will in random order be allocated to three single-dose administrations of insulin 338 in a GIPET® I tablet with 3 different coatings, respectively, on three separate dosing visits (Visits 2, 3 and 4). Each of the three dosing days will be separated by a 3-week wash-out period (ranging from 20 to 28 days) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin 338 (GIPET I) | Drug | Dose level of 8100 nmol will be orally administered as one tablet per dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin 338 concentration-time curve | From dosing to infinity calculated from a 0-288 hours NNC0123-0000-0338 serum concentration-time-curve based on 38 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) | |
| Area under the glucose infusion rate (GIR)-time curve | From 0 to 24 hours after a single 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 |
|---|---|---|---|---|---|---|
| Neuss | 41460 | Germany |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Number of treatment emergent adverse events | As recorded from trial product administration (Day 1) at Sub-visit A and until Sub-visit G (Day 13) |
| 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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