Plasma and Intrapulmonary Concentrations Study of WCK 5222
NCT ID: NCT03630094
Last Updated: 2018-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2017-03-31
2017-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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FEP-ZID via intravenous
total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen
FEP-ZID
A total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen
Interventions
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FEP-ZID
A total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen
Eligibility Criteria
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Inclusion Criteria
* Medical history without any major pathology as judged by the Investigator.
* Forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at screening.
Exclusion Criteria
* Positive alcohol breath test or urine drug screen test at screening or confinement.
* Current use or has used tobacco or nicotine containing products 6 month prior to screening.
* Positive testing for HIV, Hepatitis B or Hepatitis C.
* History or presence of alcohol or drug abuse within the 2 years prior to screening.
18 Years
55 Years
ALL
Yes
Sponsors
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Wockhardt
INDUSTRY
Responsible Party
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Locations
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Pulmonary Associates
Phoenix, Arizona, United States
Countries
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Other Identifiers
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W-5222-104
Identifier Type: -
Identifier Source: org_study_id
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