Status:
COMPLETED
Study to Determine and Compare Plasma and Intrapulmonary Pharmacokinetics of WCK 2349 in Healthy Adult Human Subjects
Lead Sponsor:
Wockhardt
Collaborating Sponsors:
Clinartis
Conditions:
Intrapulmonary Pharmacokinetics of WCK 2349
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study to determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349 in healthy adult subjects.
Eligibility Criteria
Inclusion
- Healthy adult males or females, 18 to 55 years of age (both inclusive) at the time of screening.
- Medical history without any major pathology as judged by the Principal Investigator.
Exclusion
- History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Positive urine drug/alcohol testing at screening or confinement.
- Positive testing for HIV, Hepatitis B or Hepatitis C.
- History or presence of alcohol or drug abuse within the 2 years prior to screening.
- Excessive intake of alcohol, defined as an average daily intake of greater than three units, or an average weekly intake of greater than 21 units (one unit is equivalent to 1 can or bottle (12 oz) of beer, or 1 measure (1.5 oz) of spirits, or 1 glass (5 oz) of wine) in the last 6 months prior to screening.
- Known hypersensitivity to quinolones/fluoroquinolones.
- History of allergic or other serious adverse reactions to benzodiazepines or lidocaine.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02253342
Start Date
September 1 2014
End Date
August 1 2015
Last Update
October 29 2015
Active Locations (1)
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1
Pulmonary Associates, 1112 E. McDowell Rd.
Phoenix, Arizona, United States, 85006