NL-OMON50101
Completed
Not Applicable
A trial to assess the injection site pain experience of excipient solutions relevant for subcutaneous injection - Injection site pain comparison of excipient solutions
ovo Nordisk0 sites108 target enrollmentTBD
Conditionsn.a.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- n.a.
- Sponsor
- ovo Nordisk
- Enrollment
- 108
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, aged 18 to 69 years (both inclusive) at the time of signing
- •informed consent.
- •BMI \>\=25\.0 and \<30\.0 kg/m2\.
- •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) \>\=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
Outcomes
Primary Outcomes
Not specified
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Unknown
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