Renal Impairment
Conditions
Brief 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).
Interventions
DRUGCefepime and Tazobactam combination
Sponsors
Clinartis
Wockhardt
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
-Patients with renal impairment: mild, moderate, severe and patients on hemodialysis) that has been stable OR * Healthy Subjects: * Have normal renal function * No evidence of any disease or condition that may affect pharmacokinetics of FEP-TAZ.
Exclusion criteria
* Evidence of hepatorenal or nephritic syndrome * Any clinically significant abnormal findings on medical history, physical examination,or clinical laboratory tests (other than those associated with controlled diabetes,hypertension, hypercholesterolemia, dyslipidemia, or renal impairment or related or causative diseases)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentrations (Cmax) | 48 hrs |
| Tmax The elimination half-life (t1/2), | 48 hrs |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Abnormal Laboratory Values | 14 days |
| Number of Participants With Adverse Events | 14 days |
Countries
United States
Outcome results
None listed