Phase-I Double-blind, Randomized, Placebo-controlled Single Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349 Under Fasting Conditions in Adult Healthy Human Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Wockhardt
- 入组人数
- 36
- 主要终点
- To evaluate the pharmacokinetics of multiple doses of WCK 2349
研究概览
简要总结
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, tolerability and pharmacokinetic data with the data observed in similar studies conducted in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
WCK 2349
WCK 2349 800mg, 1000mg, and 1200mg . 1 dose given orally twice daily at 12 hourly interval for five days.
Dosage form : Oral
干预措施: WCK 2349 Oral (Drug)
Placebo
Matching Placebo administered as Oral
干预措施: Placebo Oral (Other)
结局指标
主要结局
To evaluate the pharmacokinetics of multiple doses of WCK 2349
时间窗: 5 days
Measuring Cmax Maximum observed plasma concentration.
To evaluate the safety & tolerability of multiple doses of WCK 2349
时间窗: 12 days
By monitoring the adverse events reported
次要结局
未报告次要终点