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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02709382
Other study ID # W-4282-104
Secondary ID
Status Completed
Phase Phase 1
First received February 26, 2016
Last updated August 25, 2016
Start date March 2016
Est. completion date August 2016

Study information

Verified date August 2016
Source Wockhardt
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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)

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Drug:
Cefepime and Tazobactam combination


Locations

Country Name City State
United States University of Miami,Division of Clinical Pharmacology Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
Wockhardt Clinartis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary plasma concentrations (Cmax) 48 hrs No
Primary Tmax The elimination half-life (t1/2), 48 hrs No
Secondary Number of Participants With Abnormal Laboratory Values 14 days Yes
Secondary Number of Participants With Adverse Events 14 days Yes
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