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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT01891851
Eligibility Criteria:
Inclusion Criteria:
* non-smoking for at least 3 months prior to selection
* normal weight as defined by a Quetelet Index (Body Mass Index: weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included
* Informed Consent Form signed voluntarily, prior to the first trial related activity
* normal 12-lead electrocardiogram (ECG) at screening
* healthy on the basis of a medical evaluation and results fo the laboratory tests at screening.
Exclusion Criteria:
* past history of heart arrhythmias,
* female, except if postmenopausal for more than two years, or post-hysterectomy or post-tubal ligation (without reversal operation)
* history or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use
* hepatitis A, B and C infections or human immunodeficiency virus type 1 (HIV-1) or HIV-2 infections at study screening
* donation of blood or plasma in the 60 days preceding the first intake of trial medication
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01891851
Study Brief:
Protocol Section:
NCT01891851