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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT03096756
Eligibility Criteria:
Inclusion Criteria:
1. Healthy men and women, age 18 and 50 years
2. Body Mass Index (BMI) 18 to 32 kg/m2, and weighing at least 50 kg at screening.
3. Blood pressure and heart rate within normal limits
4. Non-lactating, non-pregnant female, confirmed by urine pregnancy screening and willing to use acceptable methods of birth control, per medical and institutional practice.
Exclusion Criteria:
1. History of any chronic disease; or significant medical condition within three months, including but not limited to human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
2. Use of any prescription or over-the-counter medication within one week prior to baseline
3. Anticipated need for any medication during the course of the study, with the exception of contraceptive and hormone replacement therapy
4. Use of any medications that at risk for causing a precipitous decrease in blood pressure, (e.g., nitrates or erectile dysfunction drugs, from 24 hours prior to screening and throughout participation in the study)
5. Use of any vitamin or mineral supplement 24 hours prior to dosing, or anticipated use of any vitamin or mineral supplement throughout the duration of the study;
6. History of substance abuse, drug addiction, or alcoholism within 3 years prior to Baseline and/or the inability to abstain from alcohol, or drug use from 48 hours prior to the administration of study drug and throughout the duration of the study as confirmed by toxicology screens during Screening and at Baseline
7. History of smoking or any use of a tobacco product within six months prior to Baseline and/or the inability to abstain from tobacco or caffeine use from 48 hours prior to the administration of study drug and throughout the duration of the study.
8. Donation of blood or blood products within 30 days prior to the Baseline
9. Subject has previously participated in this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03096756
Study Brief:
Protocol Section:
NCT03096756