To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment
Status:
Completed
Trial end date:
2017-04-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male and
female subjects with normal and impaired renal function. The study will be composed of five
groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients) renal
impairment, end stage renal disease patients on hemodialysis (6 patients) and their
respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function).
The severity of renal impairment will be assessed based on estimated creatinine clearance
(CLCR) by the Cockcroft-Gault equation