NCT00863577已完成1 期
Pharmacokinetic Study of Two Oral Bemiparin Formulations
Rovi Pharmaceuticals Laboratories2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2009年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- The primary pharmacokinetic analysis will be the correlation of the AUC amidolytic anti-Xa activity
研究概览
简要总结
The primary pharmacokinetic analysis will be the correlation of the AUC amidolytic anti-Xa activity
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 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
- •Healthy volunteers: male or female subjects aged between 18 and 45 years
- •Body weight: 65-80 Kg
- •Not meaningful abnormalities in physical examination and in clinical history
- •Without evidence of significant organic or psychiatric illness
- •Hemogram, biochemistry and coagulation in normal values established in the reference range of the local hospital laboratory
- •Vital signs (blood pressure, heart beat rate and body temperature) and EKG within normal range
- •Healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months
- •Not give blood in the last 4 weeks.
- •Healthy male volunteers who have not received heparin in the past
- •Healthy male volunteers who have accepted to participate in the study and have signed the written informed consent
- •contraceptive methods double barrel or sterile surgery
排除标准
- •Previous history of alcoholism, drug dependency, drug abuse or habitual psychoactive drugs consumption
- •Important consumption of exciting drinks: alcohol consumption > 30 g/day; coffee, tea, cola > 5 /day
- •Allergy, idiosyncrasy or hypersensitivity to medicines
- •Healthy volunteers who are receiving another medication in the past 15 days
- •Positive serology of hepatitis B, C or HIV
- •Cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematologic, psychiatric, neurological and others events
- •Mayor Surgery in the last 6 months
- •Smoking > 10 cigarettes / day
- •Ethanol, cannabis, cocaine, amphetamine, benzodiazepin or opiate in urine
- •Healthy volunteers with a familiar history evident hemorrhagic episodes
- •positive fecatest and comburtest
- •positive pregnant test
- •Bemiparin contraindication
结局指标
主要结局
The primary pharmacokinetic analysis will be the correlation of the AUC amidolytic anti-Xa activity
时间窗: pre-medication, +1 h , +2 h, +3h, +4 h , +5h, +6 h, +8 h, +10h, +12h, +18 h, +24 h,+25h, +26h, +27h, +28h, +29h, +30h, +32h, +34h, +36h, +42h, +48 h, +60 h and +72 h
次要结局
未报告次要终点
研究者
研究点 (2)
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