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A Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-03882845 In Healthy Volunteers - NCT00971802-33143(Clinical Trial 319691)



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City:  South Miami
State:  
FL
Zip Code: 33143
Conditions: Healthy Volunteers
Purpose: To evaluate the safety and tolerability of PF-03882845 in Healthy Volunteers. To evaluate the pharmacokinetics of PF-03882845 in Healthy Volunteers. To evaluate the pharmacodynamics of PF-03882845 in Healthy Volunteers.
Study summary:
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.
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Data Source: ClinicalTrials.gov
Date Processed: February 17, 2010
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