Plasma and Intrapulmonary Concentrations Study of WCK 5222

• Status: Completed
• Trial end date: 2017-07-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1, multiple dose, open-label pharmacokinetic study in healthy adult male and female subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wockhardt

Criteria

Inclusion Criteria:

• Body mass index (BMI) greater than or equal to18.5 and less than or equal to 30 (kg per m2) and weight between 55.0 and 100.0 kg (both inclusive).

• 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:

• History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal,endocrine, immunologic, dermatologic, neurological, or psychiatric disease.

• 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.