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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT00841594
Eligibility Criteria:
Inclusion Criteria:
* 18 to 50 years of age
* Subjects who do not take any prescription medication or who can safely discontinue use prior to visit 1.
* Negative pregnancy test for fertile women and agree to use effective contaception throughout the study.
Exclusion Criteria:
* Subjects who can not safely discontinue current prescription medications.
* Subjects who have a known allergy to nitroglycerin or common topical formulation ingredients.
* Subjects with an unstable medical problem.
* Subjects who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.
* Subjects who participated in a study of any investigational drug or device within four weeks prior to Visit 1.
* Subjects who have screening laboratory values which are outside the normal range and which are considered to be clinically significant to the investigator.
* Subjects who have had major abdominal, thoracic, or vascular surgery within six months of Visit 1.
* Subjects with non-epithelialized skin lesions or interfering skin conditions at time of screening in the area where either study medication is to be applied.
* Pregnant or nursing women.
* Women of childbearing potential who are unable or unwilling to comply with the contraceptive requirements during the study period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00841594
Study Brief:
Protocol Section:
NCT00841594