Effects Of Eplerenone On Serum Aldesterone And Plasma Renin Activity

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

To evaluate the changes in serum aldosterone and plasma renin activity on Day 0 and on Days 1 and 10 after administration of 100 mg of eplerenone daily for 10 days.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Eplerenone; Spironolactone

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

• Subjects with a supine BP greater than or equal to 140 mm Hg systolic or greater than or equal to 90 mm Hg diastolic or <100 mm Hg systolic and <60 mm Hg diastolic on a single measurement, as described in the protocol

• Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing

• History of sensitivity to eplerenone, spironolactone or related compounds.

• Serum potassium >5.0 mEq/L at screening or Day 0