Plasma and Intrapulmonary Concentrations Study of WCK 5222

Completed · Phase 1

Conditions studied: PHA1A

In brief

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

Key facts

Study ID

NCT03630094

Run by

Wockhardt

People needed

36

Starts

2017-03-31

Expected to finish

2017-07-30

Last updated by the study team

2018-08-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pulmonary Associates — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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