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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT02463357
Eligibility Criteria:
Inclusion Criteria:
* healthy,
* young (18-30 years old) men who can meet APFT requirements for special operation forces (SOF) training as outlined by the US Army (42 push ups, 53 sit-ups, 6 pull-ups, 2 mile run in \< 15 min 54 s)
Exclusion Criteria:
* women;
* smokers;
* participants with diseases or disorders known to be affected by hypoxia or the drugs used in this study, such as hypotension, anemia, sickle cell trait or disease, and diabetes;
* participants with a history of significant head injury, migraines or seizures;
* participants taking any medication (over-the-counter or prescription) or herbal supplements;
* participants with known flavonoid allergies;
* participants with known allergies to metformin;
* participants with known hypersensitivity reaction to nifedipine;
* participants with known allergies to sulfonamide-based drugs;
* participants with inability to be headache-free when consuming the amount of caffeine in two six ounce cups of coffee or less per day;
* exposure to high altitude above 1000m in the previous three months; or
* participants who have been on an airline flight over six hours (the lowered cabin pressure for an extended period of time approximates exposure to high altitude);
* participants who are unable to achieve the minimum physical criteria required for SOF training
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT02463357
Study Brief:
Protocol Section:
NCT02463357