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 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
NCT ID:
NCT00969592
Eligibility Criteria:
Inclusion Criteria:
* Overtly healthy males or females (Women: contraception, Pearl Index \<1%)
* Between the ages of 18 and 65 years
* Body Mass Index of \<= 27 kg/m²
* Safety lab within reference range
* Normal blood pressure and heart rate
* Sufficient venous access
* Written informed consent approved by the Ethical Review Board
* HbA1c and fasting plasma glucose in the normal range
Exclusion Criteria:
* Investigative site personnel directly affiliated with this study and their immediate families or the sponsor´s employees
* Within 30 days of the initial dose of study drug had received treatment with a drug that had not received regulatory approval
* Known allergies to insulin or related compounds
* Regular treatment with any drug, both over-the-counter or prescribed
* an abnormality in the 12-lead ECG increasing the risk for participation
* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Significant active neuropsychiatric disease
* Regular use of drugs of abuse and or positive findings on urinary drug screening
* Evidence of HIV and/or positive antibodies 1 or 2 and or HIV1 antigen
* Evidence of hepatitis B and/or positive hepatitis C antibody
* Evidence of hepatitis B and/or positive hepatitis B surface antigen
* Women with a positive pregnancy test or breastfeeding women
* Blood donation more than 500 mL within the last 3 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00969592
Study Brief:
Protocol Section:
NCT00969592