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NCT02709382 · ClinicalTrials.gov registry record · Phase 1
A Single-dose Study to Investigate the Pharmacokinetics of Intravenous FEP-TAZ in Patients With Renal Impairment
A Phase 1 study, sponsored by Wockhardt.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT02709382 is a Phase 1 study that has completed, run by Wockhardt. The registered enrollment target is 48 participants.
The verdict
NCT02709382, a Phase 1 study, has completed, sponsored by Wockhardt.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study 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
- DRUG Cefepime and Tazobactam combination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2016-03 |
| Est. Completion | 2016-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02709382
The ClinicalTrials.gov registry entry for NCT02709382 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wockhardt, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cefepime and Tazobactam combination is the first listed.
NCT02709382 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02709382 about?
NCT02709382 is a clinical study titled "A Single-dose Study to Investigate the Pharmacokinetics of Intravenous FEP-TAZ in Patients With Renal Impairment". 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 ...
What is the current status of trial NCT02709382?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2016-03. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02709382?
The interventions under investigation include: Cefepime and Tazobactam combination (DRUG).
Who is sponsoring clinical trial NCT02709382?
This trial is sponsored by Wockhardt, which has 27 total clinical trials registered on ClinicalTrials.gov.
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