Phase I, Open Label,Crossover Food-Effect and Absolute Bioavailability Study of WCK2349 and WCK771 in Healthy Adult Human Volunteers
Completed · Phase 1
Conditions studied: Effect of Food
In brief
This study is aimed to ascertain the effect of food on pharmacokinetics of WCK 2349 and determine the absolute bioavailability of WCK 2349 1000 mg (oral, QD dose) with respect to WCK 771 800 mg (intravenous, QD dose). This study would ascertain/confirm the therapeutically equivalent oral and IV doses of WCK 2349 and WCK 771 respectively, and provide guidance in case of switch over therapy (WCK 771, IV to WCK 2349, oral) in future clinical trials in patients.
Key facts
- Study ID
- NCT01875939
- Run by
- Wockhardt
- People needed
- 12
- Starts
- 2013-06-01
- Expected to finish
- 2013-06-01
- Last updated by the study team
- 2013-08-22
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- If female, postmenopausal for at least 1 year,surgically sterile or birth control measures.
- Body Mass Index (BMI) between 18 and 32
- No significant diseases
- No recent history of smoking or alcohol
You may not qualify if…
- Known history of hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs.
- History or evidence of disease or condition which might compromise the haemopoietic, renal, hepatic,endocrine, pulmonary, central nervous, cardiovascular,immunological, dermatological, gastrointestinal or any other body system.
- No receipt of a prescription drug or non-prescription drug .
Where it is running
- PPD Phase I unit, 7551 Metro Center Drive, Suite 200 — Austin, Texas, United States
Full record on ClinicalTrials.gov
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