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Injection Site Pain Comparison of Excipient Solutions

18 de octubre de 2021 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Obesidad

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

108

Fase

Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Países Bajos
- - Groningen, Países Bajos, 9728 NZ
    - Novo Nordisk Investigational Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

Niño
Adulto
Adulto Mayor

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Propósito principal: Otro
Asignación: Aleatorizado
Modelo Intervencionista: Asignación Secuencial
Enmascaramiento: Cuadruplicar

Número de brazos

Armas e Intervenciones

Grupo de participantes/brazo	Intervención / Tratamiento
Experimental: 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.	Otro: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Otro: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Otro: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Otro: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Otro: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Otro: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Otro: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Otro: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Otro: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Otro: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: 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
Experimental: 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.	Otro: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Otro: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Otro: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Otro: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Otro: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Otro: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Otro: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Otro: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Otro: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Otro: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: 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
Experimental: 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.	Otro: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Otro: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Otro: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Otro: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Otro: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Otro: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Otro: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Otro: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Otro: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Otro: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: 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
Experimental: 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.	Otro: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Otro: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Otro: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Otro: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Otro: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Otro: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Otro: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Otro: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Otro: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Otro: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: 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
Experimental: 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.	Otro: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Otro: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Otro: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Otro: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Otro: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Otro: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Otro: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Otro: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Otro: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Otro: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: 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
Experimental: 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.	Otro: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Otro: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Otro: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Otro: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Otro: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Otro: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Otro: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Otro: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Otro: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Otro: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: 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
Experimental: 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.	Otro: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Otro: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Otro: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Otro: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Otro: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Otro: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Otro: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Otro: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Otro: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Otro: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: 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
Experimental: 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.	Otro: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Otro: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Otro: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Otro: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Otro: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Otro: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Otro: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Otro: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Otro: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Otro: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: 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
Experimental: 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.	Otro: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Otro: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Otro: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Otro: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Otro: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Otro: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Otro: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Otro: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Otro: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Otro: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: 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
Experimental: 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.	Otro: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Otro: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Otro: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Otro: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Otro: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Otro: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Otro: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Otro: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Otro: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Otro: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: 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
Experimental: 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.	Otro: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Otro: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Otro: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Otro: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Otro: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Otro: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Otro: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Otro: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Otro: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Otro: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: 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
Experimental: 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.	Otro: Trial product 1 Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL Otro: Trial product 2 Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL Otro: Trial product 3 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL Otro: Trial product 4 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL Otro: Trial product 5 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL Otro: Trial product 6 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL Otro: Trial product 7 Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL Otro: Trial product 8 Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL Otro: Trial product 9 Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL Otro: Trial product 10 Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: Trial product 10 Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL Otro: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Intensity of injection site pain Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Novo Nordisk A/S

Investigadores

Director de estudio: Clinical Reporting Anchor and Disclosur (1452), Novo Nordisk A/S

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

20 de julio de 2020

Finalización primaria (Actual)

24 de septiembre de 2020

Finalización del estudio (Actual)

25 de septiembre de 2020

Fechas de registro del estudio

Enviado por primera vez

20 de julio de 2020

Primero enviado que cumplió con los criterios de control de calidad

20 de julio de 2020

Publicado por primera vez (Actual)

22 de julio de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de octubre de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

18 de octubre de 2021

Última verificación

1 de octubre de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

NN9838-4703
U1111-1250-7817 (Otro identificador: World Health Organization (WHO))

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

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Ensayos clínicos sobre Trial product 1

University of Pennsylvania

Reclutamiento

Reducción del recuerdo de la memoria del paciente en la población de pacientes con ardor bucal

Síndrome de boca ardiente

Estados Unidos
Suranaree University of Technology

Terminado

El biosensor de COV en orina objetivo para la detección de neoplasias malignas genitourinarias

El fenómeno de la disminución de la resistencia eléctrica dentro de las cámaras conductoras, provocando el aumento de una propiedad conductora.

Tailandia
Radicle Science

Reclutamiento

Radicle Relief 2: un estudio de productos de salud y bienestar sobre el dolor y los resultados de salud

Dolor | Dolor neuropático | Dolor nociceptivo

Estados Unidos
Pennington Biomedical Research Center
Samsung

Terminado

Calibre el BIA de Samsung para medir la composición corporal (Samsung)

Composición corporal | Medidas de circunferencia | Mediciones de espesor de tejido

Estados Unidos
Orasis Pharmaceuticals Ltd.

Terminado

Una evaluación multicéntrica de doble enmascaramiento de la eficacia y seguridad de CSF-1 en el tratamiento de la presbicia

Presbicia

Estados Unidos
University of Thessaly

Terminado

Cinética de recuperación después del entrenamiento de mantenimiento de velocidad y resistencia

Daño muscular

Grecia
University of Sao Paulo General Hospital

Terminado

Comparación de dos regímenes de aplicación de viscosuplementación

Osteoartritis

Brasil
Chulalongkorn University

Terminado

Efecto agudo del ejercicio interválico de alta intensidad en pacientes con rinitis alérgica

Rinitis alérgica

Tailandia
University of Sao Paulo General Hospital

Terminado

Comparación de protocolos de estimulación eléctrica del nervio tibial posterior para el síndrome de vejiga hiperactiva

Síndrome de vejiga hiperactiva

Brasil
Montreal Heart Institute
Institut de Recherches Cliniques de Montreal; Royal Victoria Hospital, Canada; Queen... y otros colaboradores

Terminado

Un estudio para evaluar los efectos reguladores de los lípidos de la 1-metilnicotinamida (1-MNA)

Hipertrigliceridemia

Canadá

Injection Site Pain Comparison of Excipient Solutions

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

Descripción general del estudio

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¿Cómo está diseñado el estudio?

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Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Ensayos clínicos sobre Trial product 1

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