CTRI/2012/03/002485已完成1 期
A randomized, double-blind, active-controlled, cross over, single dose study to assess the safety, tolerability and pharmacokinetics of enteric coated compound B09 in healthy male subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Adverse events, vital signs, clinical laboratory tests, ECG
研究概览
简要总结
It is a randomized, double-blind, active-controlled, cross over, single dose study to assess the safety, tolerability and pharmacokinetics of enteric coated compound B09 in healthy male subjects
The objective of this study is to monitor the safety of the subjects participating in the study and to assess the tolerability and pharmacokinetics of the enteric coated compound B09 of Sun Pharma Advanced Research Company Limited (SPARC Ltd.), India given as single dose in 12 healthy male subjects.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Availability of subject for the entire study period and willingness to adhere to protocol requirements.
- •2.Healthy male subjects, 18 to 45 years of age, subjects having weight at least 50Kg and the subject’s body mass index (BMI) must be within 18.5 – 25.0 (Kg/m2) (inclusive).
- •3.Subjects who have no evidence of underlying disease during screening medical history and whose general examination is performed within 21 days prior to commencement of the study.
- •4.Subjects whose screening laboratory values are within normal limits or considered by the Principal Investigator/Sub-Investigator to be of no clinical significance.
- •5.Informed consent form given in written form.
排除标准
- •1.History or presence of significant: 1.1Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Baclofen and/or any related compounds etc.
- •1.2Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •1.3Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year.
- •1.4Smoking (≥ 10 cigarettes/day) or consumption of tobacco products (≥ 4 chews/day).
- •1.5History of difficulty in swallowing or coming for follow up.
- •1.6Clinically significant illness within 4 weeks before the start of the study 1.7Subjects who have been on an abnormal diet (for whatever the reason) during the four weeks preceding the study 1.8Positive result to HIV, HCV and HBs-Ag. 1.9Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Gresiofulvine etc.) in the previous 30 days before day 1 of this study.
- •1.10Abnormal 12 lead ECG, X-ray.
- •2.Donation of 350 ml or more of blood in the previous 90 days before day 1 of this study.
- •3.Participation in another clinical trial within the preceding 90 days of study starts.
- •4.Subjects who have: 4.1Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg 4.2Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations ( 2-4mm Hg) at check-in may be acceptable at the discretion of the principal investigator.
- •4.3Pulse rate below 60/min.
- •or above 100/min.
结局指标
主要结局
Adverse events, vital signs, clinical laboratory tests, ECG
时间窗: Baseline, Check-in of each period, Post study within 14 days
次要结局
- Pharmacokinetics parameters(pre-dose, 0.167, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12, 16, 20, 24, 36 hours after dose for each period)
研究者
研究点 (1)
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