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Injection Site Pain Comparison of Excipient Solutions

18 oktober 2021 bijgewerkt door: Novo Nordisk A/S

A Trial to Assess the Injection Site Pain Experience of Excipient Solutions Relevant for Subcutaneous Injection

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Obesitas

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

108

Fase

Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Nederland
- - Groningen, Nederland, 9728 NZ
    - Novo Nordisk Investigational Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Kind
Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

Male or female, aged 18 to 69 years (both inclusive) at the time of signing informed consent.
Body Mass Index (BMI) equal to or above 25.0 and below 30.0 kg/m^2.
Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the Investigator.

Exclusion Criteria:

Female who is pregnant, breast-feeding or intends to become pregnant within 1 week of Day 2 or is of childbearing potential and not using highly effective contraceptive methods.
Any disorder which in the Investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
Glycated haemoglobin (HbA1c) equal to or above 6.5 % (48 mmol/mol) at screening.
Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication (when not used in the abdominal area), contraceptives or occasional use of paracetamol (not allowed within 24 hours prior to Trial Product administration), within 14 days prior to Day 1.
Average intake of more than 21 units of alcohol per week for male subjects and more than 14 units per week for female subjects: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits.
Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and admission to the clinical research centre.
Use of tobacco and nicotine products, defined as any of the below:
Smoking more than 1 cigarette or the equivalent per day on average.
Not able or willing to refrain from smoking and use of nicotine substitute products during the in-house period.
Subject is not able to understand and read English or Dutch, or subject is not able to understand and comply with the trial requirements.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Ander
Toewijzing: Gerandomiseerd
Interventioneel model: Sequentiële toewijzing
Masker: Verviervoudigen

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm	Interventie / Behandeling
Experimenteel: S1 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.	Ander: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Ander: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Ander: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Ander: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Ander: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Ander: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Ander: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Ander: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Ander: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Ander: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 12 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
Experimenteel: S2 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.	Ander: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Ander: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Ander: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Ander: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Ander: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Ander: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Ander: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Ander: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Ander: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Ander: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 12 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
Experimenteel: S3 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.	Ander: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Ander: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Ander: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Ander: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Ander: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Ander: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Ander: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Ander: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Ander: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Ander: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 12 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
Experimenteel: S4 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.	Ander: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Ander: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Ander: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Ander: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Ander: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Ander: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Ander: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Ander: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Ander: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Ander: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 12 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
Experimenteel: S5 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.	Ander: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Ander: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Ander: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Ander: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Ander: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Ander: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Ander: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Ander: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Ander: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Ander: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 12 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
Experimenteel: S6 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.	Ander: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Ander: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Ander: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Ander: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Ander: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Ander: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Ander: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Ander: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Ander: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Ander: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 12 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
Experimenteel: S7 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.	Ander: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Ander: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Ander: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Ander: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Ander: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Ander: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Ander: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Ander: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Ander: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Ander: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 12 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
Experimenteel: S8 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.	Ander: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Ander: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Ander: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Ander: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Ander: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Ander: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Ander: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Ander: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Ander: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Ander: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 12 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
Experimenteel: S9 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.	Ander: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Ander: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Ander: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Ander: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Ander: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Ander: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Ander: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Ander: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Ander: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Ander: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 12 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
Experimenteel: S10 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.	Ander: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Ander: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Ander: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Ander: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Ander: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Ander: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Ander: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Ander: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Ander: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Ander: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 12 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
Experimenteel: S11 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.	Ander: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Ander: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Ander: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Ander: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Ander: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Ander: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Ander: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Ander: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Ander: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Ander: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 12 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
Experimenteel: S12 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.	Ander: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Ander: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Ander: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Ander: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Ander: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Ander: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Ander: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Ander: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Ander: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Ander: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Ander: Trial product 12 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Intensity of injection site pain Tijdsspanne: 1 min after each injection (Day 1 and Day 2)	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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Novo Nordisk A/S

Onderzoekers

Studie directeur: Clinical Reporting Anchor and Disclosur (1452), Novo Nordisk A/S

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 juli 2020

Primaire voltooiing (Werkelijk)

24 september 2020

Studie voltooiing (Werkelijk)

25 september 2020

Studieregistratiedata

Eerst ingediend

20 juli 2020

Eerst ingediend dat voldeed aan de QC-criteria

20 juli 2020

Eerst geplaatst (Werkelijk)

22 juli 2020

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 oktober 2021

Laatste update ingediend die voldeed aan QC-criteria

18 oktober 2021

Laatst geverifieerd

1 oktober 2021

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

NN9838-4703
U1111-1250-7817 (Andere identificatie: World Health Organization (WHO))

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Beschrijving IPD-plan

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Trial product 1

The University of Texas Health Science Center,...
Children's Hospital of Philadelphia; National Institute of Diabetes and Digestive...

Voltooid

Beoordeling van de haalbaarheid van N-van-1-onderzoeken bij kinderen met hypertensie en chronische nierziekte

Hypertensie | Chronische nierziekten

Verenigde Staten
University Health Network, Toronto

Nog niet aan het werven

Gericht afschrijven bij patiënten die hemodialyse ondergaan

Eindstadium nierziekte bij dialyse (diagnose)

Canada
Abbott Nutrition

Nog niet aan het werven

Te vroeg geboren baby's kregen een versterker van moedermelk

Groei
Universidad Católica San Antonio de Murcia

Voltooid

Evaluatie van cognitieve prestaties in 4 zuiveldranken (COG)

Cognitieve prestaties

Spanje
University of Pennsylvania

Werving

Vermindering van het terugroepen van het geheugen van de patiënt in de patiëntenpopulatie met brandende mond

Brandend Mond Syndroom

Verenigde Staten
Shenzhen Precision Health Food Technology Co. Ltd...

Voltooid

De werkzaamheid van witte bonen op de orale glucosetolerantietest

Suikerziekte | Suiker; Bloed, hoog

China
Altria Client Services LLC

Voltooid

Studie ter evaluatie van veranderingen bij rokers die on!® nicotinezakjes gebruiken

Tabak gebruik

Verenigde Staten
Memorial Hospital of Rhode Island
National Heart, Lung, and Blood Institute (NHLBI)

Voltooid

Richtlijnen voor ATP III-cholesterolbeheer vertalen naar de eerstelijnszorg

Hart-en vaatziekte | Hypercholesterolemie | Basisgezondheidszorg | Beheer, risico

Verenigde Staten
Danone Asia Pacific Holdings Pte, Ltd.
Nutricia Research

Voltooid

Nieuwe proef met zuigelingenvoeding bij onderwerpen op gezonde termijn over groei, lichaamssamenstelling, tolerantie en veiligheid (Venus)

Gezond

Singapore
KGK Science Inc.
Lonza Inc.

Voltooid

Een klinische pilotproef naar de werkzaamheid van twee op carnitine gebaseerde producten op de spierfunctie bij gezonde oudere volwassenen (15CAHL)

Spierfunctie

Canada

Injection Site Pain Comparison of Excipient Solutions

A Trial to Assess the Injection Site Pain Experience of Excipient Solutions Relevant for Subcutaneous Injection

Studie Overzicht

Toestand

Conditie

Interventie / Behandeling

Studietype

Inschrijving (Werkelijk)

Fase

Contacten en locaties

Studie Locaties

Deelname Criteria

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Beschrijving

Studie plan

Hoe is de studie opgezet?

Ontwerpdetails

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm

Interventie / Behandeling

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat

Maatregel Beschrijving

Tijdsspanne

Medewerkers en onderzoekers

Sponsor

Onderzoekers

Studie record data

Bestudeer belangrijke data

Studie start (Werkelijk)

Primaire voltooiing (Werkelijk)

Studie voltooiing (Werkelijk)

Studieregistratiedata

Eerst ingediend

Eerst ingediend dat voldeed aan de QC-criteria

Eerst geplaatst (Werkelijk)

Updates van studierecords

Laatste update geplaatst (Werkelijk)

Laatste update ingediend die voldeed aan QC-criteria

Laatst geverifieerd

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Beschrijving IPD-plan

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Klinische onderzoeken op Trial product 1

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Mongolia

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties