Trials / Completed
CompletedNCT02709382
A Single-dose Study to Investigate the Pharmacokinetics of Intravenous FEP-TAZ in Patients With Renal Impairment
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Wockhardt · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cefepime and Tazobactam combination |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2016-08-01
- Completion
- 2016-08-01
- First posted
- 2016-03-16
- Last updated
- 2016-08-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02709382. Inclusion in this directory is not an endorsement.