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 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT01517568
Eligibility Criteria:
Inclusion Criteria:
* Good general health as judged by the Investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs, and blood and urinary laboratory assessments
* BMI (Boday Mass Index) of 20.0-27.0 kg/m\^2, both inclusive
Exclusion Criteria:
* History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the Investigator
* Impaired renal function
* Active hepatitis B or active hepatitis C
* Positive human immunodeficiency virus (HIV) antibodies
* Any clinically significant abnormal ECG, as judged by the Investigator
* Any clinically significant abnormal laboratory test results, as judged by the Investigator
* Acute infection or inflammation or other illness that may influence the metabolism and excretion pattern of the trial product, as judged by the Investigator
* Known or suspected allergy to trial product(s) or related products
* History of alcoholism or drug abuse or positive results in alcohol and drug screens
* Smoking of more than 5 cigarettes per day
* Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the Investigator
* Excessive consumption of a diet deviating from a normal diet, as judged by the Investigator
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT01517568
Study Brief:
Protocol Section:
NCT01517568