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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1250-7817 | Other Identifier | World Health Organization (WHO) |
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The purpose of this study is to investigate different solutions used to inject drugs under the skin. The solutions used in the study do not contain the drugs they will be used for, but they do contain excipients, which are inactive substances added to drug solutions to ensure the stability (shelf life and correct activity) of the drug product. The excipients are considered 'inactive substances' compared to the drug, but they may cause an undesirable effect at the injection site in the form of pain. However, their pain-causing potential has never been tested in a systematic way. The purpose of the study is to determine if there is a difference in the injection site pain experience after an injection under the skin (subcutaneous) with 12 different study products. These study products are excipient solutions, which are substances in medications next to the active substance. None of the 12 products include active medication. This study will be performed in 108 healthy male and female volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S1 | Experimental | Day 1: Trial products 1-2-12-3-11-4 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 10-5-9-6-8-7 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. |
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| S2 | Experimental | Day 1: Trial products 2-3-1-4-12-5 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 11-6-10-7-9-8 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. |
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| S3 | Experimental | Day 1: Trial products 3-4-2-5-1-6 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 12-7-11-8-10-9 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trial product 1 | Other | Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL |
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| Measure | Description | Time Frame |
|---|---|---|
| Intensity of injection site pain | mm on a 100 mm horizontal visual-analogue scale (where 0 mm = no pain, 100 mm = unbearable pain) | 1 min after each injection (Day 1 and Day 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosur (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Groningen | 9728 NZ | Netherlands |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| S4 | Experimental | Day 1: Trial products 4-5-3-6-2-7 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 1-8-12-9-11-10 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. |
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| S5 | Experimental | Day 1: Trial products 5-6-4-7-3-8 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 2-9-1-10-12-11 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. |
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| S6 | Experimental | Day 1: Trial products 6-7-5-8-4-9 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 3-10-2-11-1-12 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. |
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| S7 | Experimental | Day 1: Trial products 7-8-6-9-5-10 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 4-11-3-12-2-1-given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. |
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| S8 | Experimental | Day 1: Trial products 8-9-7-10-6-11 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 5-12-4-1-3-2 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. |
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| S9 | Experimental | Day 1: Trial products 9-10-8-11-7-12 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 6-1-5-2-4-3 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. |
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| S10 | Experimental | Day 1: Trial products 10-11-9-12-8-1 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 7-2-6-3-5-4 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. |
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| S11 | Experimental | Day 1: Trial products 11-12-10-1-9-2 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 8-3-7-4-6-5 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. |
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| S12 | Experimental | Day 1: Trial products 12-1-11-2-10-3 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 9-4-8-5-7-6 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. |
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| Trial product 2 | Other | Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL |
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| Trial product 3 | Other | Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL |
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| Trial product 4 | Other | Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL |
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| Trial product 5 | Other | Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL |
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| Trial product 6 | Other | Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL |
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| Trial product 7 | Other | Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL |
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| Trial product 8 | Other | Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL |
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| Trial product 9 | Other | Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL |
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| Trial product 10 | Other | Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL |
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| Trial product 10 | Other | Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL |
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| Trial product 12 | Other | Buffering agent: Glutamic acid 0.46 mg/mL, Disodium hydrogen phosphate, dihydrate 2.00 mg/mL Isotonic agent: Glycerol 15 mg/mL, NaCl 2.5 mg/mL |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |