End-stage renal disease (ESRD) patients often develop cardiovascular complications, and cardiovascular disease is the leading cause of death in this population. Ranolazine's ability to treat angina without reducing heart rate or blood pressure makes it an important option for ESRD patients. The hemodialysis clearance of ranolazine is unknown. A single-dose pharmacokinetic study is needed to characterize ranolazine and its metabolites in ESRD patients on and off hemodialysis. Results of the proposed study will provide initial dosing estimates for a follow-up, multiple-dose pharmacokinetic study in this population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
A single dose of two oral ranolazine extended release 500 mg tablets
Blood samples collected to assess ranolazine plasma and dialysate concentrations.
Calculation of a QT interval will be performed throughout subject participation.
University of Michigan Hospital
Ann Arbor, Michigan, United States
Pharmacokinetic Parameters of Ranolazine
Peak Plasma Concentration (Cmax) with a 500 mg dose of ranolazine
Time frame: At hours post-dose: 0, 2, 4, 8, 12, 15, 18, 20, 22, 23, 26, 30, 65
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