Trials / Completed
CompletedNCT03630094
Plasma and Intrapulmonary Concentrations Study of WCK 5222
A Phase 1, Multiple-Dose, Open-Label Study to Determine and Compare Plasma and Intrapulmonary Concentrations of WCK 5222 (Cefepime and Zidebactam) in Healthy Adult Human Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Wockhardt · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase 1, multiple dose, open-label pharmacokinetic study in healthy adult male and female subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FEP-ZID | A total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen |
Timeline
- Start date
- 2017-03-31
- Primary completion
- 2017-06-30
- Completion
- 2017-07-30
- First posted
- 2018-08-14
- Last updated
- 2018-08-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03630094. Inclusion in this directory is not an endorsement.