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 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT01133392
Eligibility Criteria:
Inclusion Criteria:
* Are healthy males or females.
* Body mass index (BMI) between 18.5 and 29.9 kilograms per meter squared (kg/m\^2)
* Are nonsmokers.
* Have normal blood pressure and pulse rate, a normal electrocardiogram (ECG), and clinical laboratory test results within normal reference range at screening.
Exclusion Criteria:
* History of first-degree relatives known to have diabetes mellitus.
* Evidence of significant active neuropsychiatric disease.
* Evidence of an acute infection with fever or infectious disease.
* Intend to use over-the-counter or prescription medication (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods).
* Have used systemic glucocorticoids within 3 months prior to entry into the study.
* Have donated blood of 1 unit or more within the last 3 months prior to study entry.
* Excessive alcohol intake
* Have a fasting venous blood glucose (FBG, plasma) \>6 millimoles/liter (mmol/L) at screening.
* Have positive hepatitis B surface antigen.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
50 Years
Study:
NCT01133392
Study Brief:
Protocol Section:
NCT01133392