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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT00971802
Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
* Evidence or history of clinically significant disease.
* Past medical history of epididymitis, orchitis, sexually transmitted diseases (chlamydia, gonorrhea, etc.) or urinary tract infection.
* History of prostatitis or prostate surgery.
* Urinary catheterization or instrumentation within 12 months of screening. Inguinal or scrotal hernia.
* Current or history of congenital genital abnormalities.
* Baseline scrotal ultrasound scan showing unilateral or bilateral scrotal blood flow abnormalities or anatomic abnormalities (hydrocele, cysts, other), with the exception of small epididymal cysts and spermatoceles.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
* History of sensitivity to spironolactone, eplerenone, or related compounds.
* Serum potassium \>5.5 mEq/L at screening or Day 0.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00971802
Study Brief:
Protocol Section:
NCT00971802