Study to Determine and Compare Plasma and Intrapulmonary Pharmacokinetics of WCK 2349 in Healthy Adult Human Subjects

Wockhardt

Status and phase

Completed

Phase 1

Conditions

Intrapulmonary Pharmacokinetics of WCK 2349

Treatments

Drug: WCK-2349

Study type

Interventional

Funder types

Industry

Identifiers

NCT02253342

W-2349-103

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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.