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 @ 12:10 PM
Ignite Modification Date:
2025-12-24 @ 12:10 PM
NCT ID:
NCT01327261
Eligibility Criteria:
Inclusion Criteria:
* Healthy Caucasian Argentinean males and females volunteers aged 21 to 50 years with a body mass index from 19 to 27 kg/m2 were enrolled in this study.
* All volunteers provided written informed consent prior to study initiation.
Exclusion Criteria:
* History of cardiovascular, hepatic, renal, psychiatric, neurologic, hematologic, or metabolic disease
* Drug or alcohol abuse within 2 years before the start of the study
* Smoking
* HIV, hepatitis B, or hepatitis C infection
* Consumption of any prescribed or over-the-counter drug within 2 weeks before the study or
* Participation in a similar study within the past 6 months. Female subjects were not to be pregnant, planning to become pregnant, or breastfeeding at the time of the study, and were required to use an effective method of contraception (intrauterine device or hormonal method) throughout the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
50 Years
Study:
NCT01327261
Study Brief:
Protocol Section:
NCT01327261