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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT01157104
Eligibility Criteria:
Inclusion Criteria:
To participate in the study, participants must meet the following requirements:
1. Must be a healthy male or female between 19 and 65 years of age with body mass index (BMI) between 18 and 35 kg/m2.
2. Must be a non-smoker.
3. Must agree to use an acceptable double-barrier method of birth control.
4. Must provide written informed consent after the study has been fully explained.
Exclusion Criteria:
Participants are not eligible if they meet any of the following:
1. Pregnant or breastfeeding.
2. History of clinically significant diseases, as determined by the investigator.
3. Safety laboratory abnormalities at screening which are clinically significant.
4. Positive screening test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV).
5. Use of chronic prescription medications within 3 months, acute prescription medications within 14 days, or systemic over-the-counter (OTC) medications within 7 days of the starting the study.
6. Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
65 Years
Study:
NCT01157104
Study Brief:
Protocol Section:
NCT01157104