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 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT01060566
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be male or female and between 18 and 55 years of age.
* Subjects must be judged to be in good health.
* Subjects must have a body mass index (BMI) from 18 to 30 kg/m2.
Exclusion Criteria:
* History of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject.
* Subjects who have human immunodeficiency virus (HIV), hepatitis C, or active hepatitis B.
* Female subjects and female partner(s) of male subjects who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug.
* History of cardiovascular disease, hypoglycemia, or edema.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01060566
Study Brief:
Protocol Section:
NCT01060566