None listed
Conditions
Interventions
Intervention1: WCK 2349: 200 mg or 400 mg or 600 mg or 800 mg or1000 mg or 1200 mg or1500 mg
Control Intervention1: Placebo: 200 mg or 400 mg or 600 mg or 800 mg or 1000 mg or 1200 mg or 1500 mg
Sponsors
Wockhardt Ltd
Eligibility
Inclusion 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
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 &#61558; Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medication (Note: Incase the blood loss was &#8804; 200 mL, subject may be enrolled 60 days after the blood donation) &#61558; A positive hepatitis screen including hepatitis B surface antigen, HCV antigen and anti-HAV antibodies &#61558; A positive test result for HIV antibody and/or syphilis &#61558; The receipt of an investigational drug or product, or participation in a drug research study within a period of 90 days prior to the first dose of study medication (Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study) &#61558; An unusual diet (e.g. low-sodium for high blood pressure), for whatever reason, for four weeks prior to receiving the study medication and throughout the subjects? participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety & tolerability of single escalated doses of oral WCK 2349 in healthy, adult, male, human subjects. To evaluate the pharmacokinetics of single escalated doses of oral WCK 2349 in healthy, adult, male, human subjects. Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Rakesh Chugh
Wockhaardt Ltd
Outcome results
None listed