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Study to Assess Tolerability of Injecting Larger Volumes (2-5 mL) Subcutaneously at Different Rates: Participant Experience and Acceptance

RecruitingPhase 1Ages 18 Years - 64 YearsAllNovo Nordisk A/S
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In plain words

What the trial is, and whether it could suit you

The purpose of the study is to investigate the tolerability of different injection/infusion volumes and speed compared to standard practise. The order in which the different volumes and injection speeds will be given to participants will be allocated by chance. Participants will be in this clinical study for about 1 week.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Healthy male or female participants as judged by the investigator. * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body Mass Index (BMI) greater than or equal to (\>=) 18.5 and less than or equal to (\<=) 30.0 kilograms per square metre (kg/m\^2) (both included). * White (Light skin that allows for adequate medical evaluation of any skin reactions). Exclusion criteria: * Known or suspected hypersensitivity to study intervention(s) or related products. * Previous randomisation in this study. * Previous rescreening for this study. * Pregnant or breastfeeding female participants. * Current participation (i.e., signed informed consent) in any other interventional clinical study. Treatment with an investigational medical product within 3 months or 5 half-lives (if known), whichever is longer prior to screening. * Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol, including insufficient abdominal area for injection. * Intake of any medication that could influence pain perception or injection site reaction appearance (e.g., anti-coagulants, including low dose of aspirin, systemic antihistamines, pain-relieving, or anti-inflammatory medicinal products) within the last week before the intervention. * Intake of alcohol within the last 24 hours (self-reported) or a positive result of alcohol breath test prior to randomisation and intervention. * Intake of illicit drugs within the last 48 hours (self-reported) or a positive result of urine drug screening prior to screening. * Use of any nicotine products within the past month before screening. * Known active or inactive skin condition or disease, tattoos, or other interventions in the injection area that may affect pain perception or assessment of injection-site reactions. * Strenuous exercise within 3 days prior to the intervention.
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What it tests

  • Syringe Pump
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Where

1 site
Novo Nordisk Clinical Innovation Centre A/S
Gentofte Municipality, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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