CTRI/2009/091/000377
Completed
Phase 1
Phase 1 study to evaluate the safety, tolerability and pharmacokinetics of oral WCK 2349 (200 mg or 400 mg or 600mg or 800mg or 1000 mg or 1500mg) on single dose administration in adult healthy male human volunteers under fasting conditions.
Wockhardt Ltd0 sites84 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Wockhardt Ltd
- Enrollment
- 84
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy males between 18 and 45 years of age (both inclusive) living in and around the City (investigational site).
- •Having a Body Mass Index (BMI) between 18\.5 and 24\.9 (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, ECG, EEG and X\-ray recordings
- •Be able to communicate effectively with the study personnel.
- •Be able to sign the Informed Consent Form
- •Able to comply with the study related procedures
Exclusion Criteria
- •\&\#61558;Known hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs
- •\&\#61558;Any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system
- •\&\#61558;Use of any medicine within 14 days prior to start of the study. In any such case subject selection will be at the discretion of the Principal Investigator
- •\&\#61558;Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria
- •\&\#61558;A recent history of alcoholism (\<2 years) or of moderate (180mL/day) alcohol use, or consumption of alcohol within 48h of receiving study medication
- •\&\#61558;Smokers, who smoke more than 10 cigarettes / day or those who can not refrain from smoking during study period.
- •\&\#61558;The presence of clinically significant abnormal laboratory values during screening
- •\&\#61558;Use of recreational drugs or history of drug addiction or testing positive in pre\-study drug scan
- •\&\#61558;History of psychiatric disorders
- •\&\#61558;A history of difficulty with donating blood
Outcomes
Primary Outcomes
Not specified
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