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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT00513994
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers 18 - 70 years of age.
* Subjects able to give written informed consent and comply with study requirements.
* Subjects willing and able to safely discontinue all current prescription therapies.
* Subjects who will agree not to participate in other clinical trials.
* Negative pregnancy test in fertile females and agreement to use effective contraception throughout the study.
Exclusion Criteria:
* Persons who would be put at risk by discontinuing prescription therapies.
* Subjects with a known allergy to nitroglycerin.
* Subjects who have a condition or issue that would adversely affect the application of study medication, study evaluations or the subject's ability to comply with the protocol.
* Subjects who recently experienced myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension or uncontrolled hypertension.
* Subjects who have participated in a study of an investigational drug within two weeks of visit 1.
* Subjects who have screening lab values that are out of range or are considered clinically significant by the investigator.
* Subjects who have had major abdominal, thoracic, or vascular surgery within 6 months of visit 1.
* Subjects with non-epithelialized skin lesions or interfering skin conditions at the time of screening in the area where study medication is to be applied.
* Pregnant or nursing women.
* Women of childbearing potential who are unwilling to comply with the contraceptive requirements.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00513994
Study Brief:
Protocol Section:
NCT00513994