Phase-I Randomized, Open Label, Crossover Food-Effect and Absolute Bioavailability Study of WCK 2349 and WCK 771 in Healthy Adult Human Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Wockhardt
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Evaluate pharmacokinetics of WCK 2349 (Fed/Fasting)and WCK 771 Fasting
研究概览
简要总结
This study is aimed to ascertain the effect of food on pharmacokinetics of WCK 2349 and determine the absolute bioavailability of WCK 2349 1000 mg (oral, QD dose) with respect to WCK 771 800 mg (intravenous, QD dose).
This study would ascertain/confirm the therapeutically equivalent oral and IV doses of WCK 2349 and WCK 771 respectively, and provide guidance in case of switch over therapy (WCK 771, IV to WCK 2349, oral) in future clinical trials in patients.
详细描述
All the subjects will be checked-in into the clinical study facility on Day -1, the day prior to dosing. The subjects will be randomly assigned to receive WCK 2349 1000 mg as an oral dose in fed or fasting state (1:1) in the food effect study as per the randomization schedule. The subjects completing the food effect study (i.e., Period 1 and Period 2) will be administered WCK 771 800 mg as an intravenous infusion in fasting state in Period 3 of the study. There will be a washout period of three days between each period. The subjects will continue to remain in the clinical facility for the entire duration of the study (completion of three periods in the study), including wash out period. Prior to check out procedure, detailed clinical examination will be done to confirm that subject has no safety issues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
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
- •If female, postmenopausal for at least 1 year,surgically sterile or birth control measures.
- •Body Mass Index (BMI) between 18 and 32
- •No significant diseases
- •No recent history of smoking or alcohol
排除标准
- •Known history of hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs.
- •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.
- •No receipt of a prescription drug or non-prescription drug .
研究组 & 干预措施
Oral WCK 2349 fed/fasting
This is a single center, randomized, open label, 2X2 oral IV cross over, food-effect and absolute bioavailability study. The study will be conducted in three parts i.e., Period 1 and Period 2 (foodeffect study) and Period 3 (absolute bioavailability study).
干预措施: Oral WCK2349 (Drug)
IV WCK771
This is a single center, randomized, open label, 2X2 oral IV cross over, food-effect and absolute bioavailability study. The study will be conducted in three parts i.e., Period 1 and Period 2 (foodeffect study) and Period 3 (absolute bioavailability study).
干预措施: IV WCK771 (Drug)
结局指标
主要结局
Evaluate pharmacokinetics of WCK 2349 (Fed/Fasting)and WCK 771 Fasting
时间窗: Approximately 11 days
To compare the pharmacokinetics of WCK 2349 following oral administration of 1000 mg of WCK 2349 (QD, one day) in healthy, adult, human subjects in fed and fasting state To determine the absolute bioavailability of WCK 2349 following oral administration of 1000 mg of WCK 2349 (QD, one day) with respect to intravenous administration of 800 mg of WCK 771 (QD, one day) in healthy adult human subjects in fasting state.Absolute bioavailability (F) of oral WCK 2349 as compared to intravenous WCK 771 following single dose administration in healthy subjects in fasting state will be calculated as follows: F =AUC i.v /AUC oral \*Dose of oral/Dose of IV Summary statistics will be provided for the safety data.
次要结局
- safety of oral WCK 2349 and intravenous WCK 771 in healthy adult human subjects(Approximately 11 days)