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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT01688635
Eligibility Criteria:
Inclusion Criteria:
* Are overtly healthy males or females
* Have body mass index between 18.5 and 29.9 kilograms per meter square (kg/m\^2)
* Are nonsmokers and have not smoked for at least 2 months prior to entering the study
* Have normal blood pressure and pulse rates at screening
* Have electrocardiograms (ECGs) at screening considered as within normal limits
* Have clinical laboratory test results within normal reference ranges
Exclusion Criteria:
* Are currently enrolled in or discontinued within the last 30 days from a clinical study involving an investigational drug or device or are concurrently enrolled in any other type of medical research
* Have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin
* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
* Show evidence of significant active neuropsychiatric disease, including taking prescription medication for such diseases
* Show evidence of current use of known drugs of abuse or a history of use within the past year
* Have a history of first-degree relatives known to have diabetes mellitus
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies at screening
* Have positive hepatitis B surface antigen at screening
* Intend to use over-the-counter or prescription medication within 7 or 14 days, respectively, prior to dosing (apart from vitamin/mineral supplements, occasional paracetamol, thyroid replacement medication, or birth control methods)
* Have donated or had a blood loss of 450 milliliters (mL) within 3 months prior to study enrollment
* Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) or are unwilling to stop alcohol consumption from 24 hours prior to each dosing until discharged from the clinical research unit (CRU)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT01688635
Study Brief:
Protocol Section:
NCT01688635