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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT01137656
Eligibility Criteria:
Inclusion Criteria:
* Male or female and 18 to 50 years of age.
* Able to read and comprehend the English language
Exclusion Criteria:
* Less than 18 or greater than 50 years of age.
* Female \< 110 lbs or 50 kg
* Male \< 110 lbs or 50 kg
* Hemoglobin \<12.5g/dl
* Past medical history or symptoms of blood dyscrasia, diabetes mellitus, hyperlipidemia, obstructive sleep apnea, hypertension, significant cardiac disease and / or known peripheral arterial disease.
* History of cigarette smoking within the last month
* Serum creatinine \>1.0 mg/dL
* Cognitively impaired subjects, or institutionalized persons and subjects unable or unwilling to complete written informed consent (no proxy consent will be obtained)
* Subjects with a history of blood donation within the last 60 days.
* Subjects who have performed other medical studies involving drug delivery in the last 30 days.
* Subjects with an oxygen saturation value \< 92%.
* Any STATIN drug (Fluvastatin, Lovastatin, Pravastatin, Simvastatin, Rosuvastatin) currently or in the 4 weeks prior to the screening day
* Any medication for the treatment of diabetes including oral hypoglycemics or insulin
* lab tests indicating blood dyscrasia, diabetes, hypertension or hypercholesterolemia.Females of childbearing potential who are pregnant or unwilling to undergo pregnancy testing; females with positive pregnancy testing on screening day will be excluded
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01137656
Study Brief:
Protocol Section:
NCT01137656