Safety, tolerability and pharmacokinetics study of WCK 2349 (in multiple doses) in healthy male volunteer.

Phase 1

Completed

• Registration Number: CTRI/2009/091/000930
• Lead Sponsor: Wockhardt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

·Healthy males between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city of western part of India.

·Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in kg / height in m2

·Not having any significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG, EEG and X-ray recordings

·Able to comply with the study procedure, in opinion of the Investigator.

·Able to give written consent for participation in the trial.

Exclusion Criteria

·Known hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs
·Any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system
·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 / Medical Expert
·Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria
·A recent history of alcoholism (<2 years) or of moderate (180mL/day) alcohol use, or consumption of alcohol within 48hr of receiving the first dose of study medicine.
·Smokers, who smoke more than 10 cigarettes / day or those who can not refrain from smoking during study period.
·The presence of clinically significant abnormal laboratory values during screening
·Use of recreational drugs or history of drug addiction or testing positive in pre-study drug scan
·History of psychiatric disorders
·A history of difficulty with donating blood
·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)
·A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies
·A positive test result for HIV antibody and/or syphilis
·The receipt of an investigational drug or product, or participation in a drug research study within a period of 90 days prior to receiving the first dose of study medicine (Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study)
Note: If subject had participated in a study in which blood loss was &#8804; 200 mL, subject can be dosed after completion of 60 days from the previous study.
·An unusual diet (e.g. low-sodium), for whatever reason, for four weeks prior to receiving the first dose of study medicine and throughout the subject?s participation in the study. In any such case, subject selection will be at the discretion of the Principal Investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified