CTRI/2009/091/000377已完成1 期
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 个研究点目标入组 84 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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
- •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 48h of receiving study medication
- •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 ≤ 200 mL, subject may be enrolled 60 days after the blood donation)
- •A positive hepatitis screen including hepatitis B surface antigen, HCV antigen and anti-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 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)
- •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.
研究者
相似试验
已完成
不适用
Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics and pharmacodynamics of monoclonal antibody TB31F in healthy malaria-naïve adults in the NetherlandsmalariaNL-OMON50099Radboud Universitair Medisch Centrum25
招募中
1 期
Phase I study to evaluate the safety, tolerability and preliminary efficacy of the bispecific PSMAxCD3 antibody CC-1 in men with biochemical recurrence of prostate cancerbiochemical recurrence after curativelyintended therapy for localized PCDRKS00031816niversitätsklinikum Tübingen38
进行中（未招募）
不适用
Clinical trial to assess the safety, tolerability, pharmacokinetics and anti-tumor activity of HM95573 in solid tumorNeoplasmsKCT0001539Hanmi Pharm72
已完成
1 期
A Phase 1 study to assess the safety, tolerability, and immunogenicity of VN-0200 after intramuscular injection in Japanese healthy adults and elderly subjectsPrevention of respiratory syncytial virusJPRN-jRCT2031210069Inoguchi Akihiro48
已完成
1 期
Safety and pharmacokinetics study in healthy Japanese volunteersJPRN-jRCT2051210087Owada Yasuko48