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:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT00915434
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteer between the ages of 18-55
* if a woman, must be of non childbearing potential (ie, post menopausal or surgically sterile) and have a negative pregnancy test
* body mass index between 18-30
* body weight greater than or equal to 50 kilograms
* blood pressure between 90 and 140 mgHg systolic and no higher than 90 mgHg diastolic
* nonsmoker
Exclusion Criteria:
* History of or current clinically significant medical illness
* clinically significant abnormal laboratory value(s)
* clinically significant abnormal physical examination, vital signs or electrocardiogram
* pregnant, lactating or completed last term pregnancy within six months of screening
* use of any prescription or non prescription medication except for paracetamol (acetaminophen/TYLENOL)
* history of drug or alcohol abuse
* history of smoking or use of nicotine-containing substances within the previous two months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00915434
Study Brief:
Protocol Section:
NCT00915434