CTRI/2012/03/002497Other1 期
Effect of 1334H (Escalating Doses)and Moxifloxacin (400 mg) compared with placebo on QT interval using time-matched 12-lead ECG in healthy subjects: A randomized, double blind, double dummy, single dose preliminary study.
试验速览
- 阶段
- 1 期
- 状态
- Other
- 入组人数
- 36
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
- •1. Availability of volunteer for the entire study period and willingness to adhere to protocol requirements.
- •2. Healthy human subjects having weight at least 50Kg and the subject¡¯s body mass index (BMI) must be within 18.5 ¨C 25.0 (Kg/m2) (inclusive).
- •3. Who voluntarily have given their written informed consent form (ICF) duly signed by the volunteer (section 12.3) to participate in the study.
- •4. Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21 days prior to commencement of the study.
- •5. Subjects whose screening laboratory values are within normal limits or considered by the physician/Clinical Investigator to be of no clinical significance.
- •6. Subjects whose 2 D-Echocardiography at screening 2 are normal will be enrolled into the study.
- •7. Subjects whose ECG¡¯s at screen 2 are within normal limits on manual reading and QTc intervals ¡Ü 450msec on instrument reading.
排除标准
- •1. Marked baseline prolongation of QT/QTc interval (repeated demonstration of a QTc interval 450 ms)
- •2. History of additional risk factors for TdP (e.g. heart failure, hypokalemia, family history of long QT syndrome)
- •3. Use of concomitant medications that prolong the QT/ QTc interval
- •4. History or presence of:
- •i. Significant history of hypersensitivity or idiosyncratic reactions to cetirizine like compounds or to Moxifloxacin or any related products
- •ii. Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •iii. Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year.
- •iv. Moderate to heavy smoking (10 cigarettes/day) or consumption of tobacco products.
- •v. History of difficulty in swallowing or coming for follow up
- •vi. Clinically significant illness within 4 weeks before the start of the study
- •vii. Female subject
- •6. Participation in another clinical trial within the preceding 90 days of study starts.
- •7. Subjects who have:
- •i. Systolic blood pressure less than 90 mm of Hg and more than 140 mm of Hg
- •ii.Diastolic blood pressure less than 60 mm of Hg and more than 90 mm of Hg. Minor deviations (1-3 mm Hg) at check-in may be acceptable at the discretion of the physician/investigator.
- •iii. Pulse rate below 60/min. and above 100/min.
- •Any waiver of these inclusion and exclusion criteria must be approved and documented by the qualified investigator and the sponsor on a case-by-case basis
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