Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT04022304
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male and post-menopausal female subjects. Post-menopausal defined as 12 months of no menses without an alternative medical cause and confirmed by a follicle stimulating hormone (FSH) level in the post-menopausal range (\>= 25.8 IU/L).
2. Age between 18 and 55 years, both inclusive
3. Body mass index between 18.5 and 29.0 kg/m\^2, both inclusive.
4. Fasting plasma glucose concentration \<= 100 mg/dl.
5. Considered generally healthy upon completion of medical history and screening safety assessments, as judged by the Investigator.
Exclusion Criteria:
1. Known or suspected hypersensitivity to Investigational Medicinal products (IMP(s)) or related products.
2. Systolic blood pressure \< 95 mmHg or \>140 mmHg and/or diastolic blood pressure \< 50 mm Hg or \>90 mmHg after resting for at least 5 minutes in supine position (excluding white-coat hypertension; therefore, a repeat test showing results within range will be acceptable).
3. Pulse rate at rest outside the range of 50-90 beats per minute.
4. Receipt of any medicinal product in clinical development within 30 days or five times its half-life (whichever is longer) before randomisation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04022304
Study Brief:
Protocol Section:
NCT04022304