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 @ 7:21 PM
Ignite Modification Date:
2025-12-24 @ 7:21 PM
NCT ID:
NCT00001303
Eligibility Criteria:
* INCLUSION CRITERIA:
1. 18 to 45 years of age, either male or female
2. Employees or non-employees are eligible
3. Normal screening examination:
1. history and physical examination, nonsmoker, no concurrent medications including aspirin or nonsteroidal anti-inflammatory drugs, no active medical problems;
2. complete blood count with differential and platelet counts;
3. serum chemistries including creatinine, blood urea nitrogen, glucose, liver enzymes and function tests, electrolytes, prothrombin time, partial thromboplastin time;
4. urinalysis;
5. female subjects must have negative urine pregnancy test within one week of participation;
6. electrocardiogram;
7. chest radiograph.
4. If age is 40 to 45 years, normal submaximal stress test to screen for asymptomatic coronary artery disease.
EXCLUSION CRITERIA:
Pregnancy.
Lactation.
History of recent clinically significant asthma.
Subjects who have an allergy to both sulfa- and penicillin-based drugs will not be eligible for the endotoxin instillation portion of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00001303
Study Brief:
Protocol Section:
NCT00001303