Overview

A Single-dose Study to Investigate the Pharmacokinetics of Intravenous FEP-TAZ in Patients With Renal Impairment

Status:
Completed
Trial end date:
2016-08-01
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).
Phase:
Phase 1
Details
Lead Sponsor:
Wockhardt
Collaborator:
Clinartis
Treatments:
Cefepime
Tazobactam