Status:
COMPLETED
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349
Lead Sponsor:
Wockhardt
Conditions:
Pharmacokinetics
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The present study is planned to assess the safety, tolerability and pharmacokinetic profile of WCK 2349 in US subjects with selected ascending multiple doses of WCK 2349 and to compare the safety, tol...
Eligibility Criteria
Inclusion
- Must be healthy males or non-pregnant females
- Have a Body Mass Index (BMI) between 18 and 32 (both inclusive), calculated as weight in kg / height in m2
- Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations and ECG recordings.
- Should test negative for drugs of abuse and urine alcohol test.
Exclusion
- Known hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs.
- Any 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.
Key Trial Info
Start Date :
March 17 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04874324
Start Date
March 17 2011
End Date
June 25 2011
Last Update
December 1 2022
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