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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT01604993
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers aged 18-50
* Must consider themselves to be in good overall health and be free of any conditions or illnesses Women must be post-menopausal or not pregnant.
* Body mass index (BMI) must be \<30kg/m\^2.
* Normotensive, as defined by brachial SBP \<140mmHg and DBP \<90mmHg
* Subjects must also be willing to stop using mouthwash for the duration of their participation in the study.
Exclusion Criteria:
* Women of childbearing age may not be pregnant, planning to become pregnant, or breastfeeding at the time of the study
* BMI \>30kg/m\^2
* Hypertensive as defined by brachial SBP \>140mmHg and/or DBP \>90mmHg
* Allergy or sensitivity to the study product, reference therapy or nitrates
* Having any gastrointestinal complication or condition
* Chronic use of medications such as prescription NSAIDs, antacids, blood-thinners, hypertensive medications, medications affecting NO synthesis such as Viagra, and use of antibiotics within one month of the study start
* Individuals who are involved in another clinical trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01604993
Study Brief:
Protocol Section:
NCT01604993