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 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT01527656
Eligibility Criteria:
Inclusion Criteria:
* Considered generally healthy upon completion of medical history and physical examination, as judged by the investigator
* Body Mass Index (BMI) between 19.0-30.0 kg/m\^2
* Glycohemoglobin (HbA1c) within laboratory normal range
* Non-smokers
Exclusion Criteria:
* Clinically significant abnormal haematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
* Liver enzyme values (ALAT and ASAT) exceeding 2 times the upper reference limit according to the local laboratory
* A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the trial or pose additional risk in administering the investigational product to the subject
* History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive urine drug screen and breath alcohol screen)
* HIV (human immunodeficiency virus), Hepatitis B or C positive
* Subjects with a first-degree relative with diabetes mellitus
* A history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions
* Known or suspected allergy to trial product or related products
* Smoking during the past three months
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01527656
Study Brief:
Protocol Section:
NCT01527656