Status:
COMPLETED
Phase I, Open Label,Crossover Food-Effect and Absolute Bioavailability Study of WCK2349 and WCK771 in Healthy Adult Human Volunteers
Lead Sponsor:
Wockhardt
Conditions:
Effect of Food
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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 (intra...
Detailed Description
All the subjects will be checked-in into the clinical study facility on Day -1, the day prior to dosing. The subjects will be randomly assigned to receive WCK 2349 1000 mg as an oral dose in fed or fa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 .
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01875939
Start Date
June 1 2013
End Date
June 1 2013
Last Update
August 22 2013
Active Locations (1)
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1
PPD Phase I unit, 7551 Metro Center Drive, Suite 200
Austin, Texas, United States, 78744