- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110
- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
- 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
- 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.