Pharmacodynamics Study of Enoxalow, Produced by Blau Farmacêutica S/A, Compared to Clexane, Produced by Sanofi-Aventis Farmacêutica Ltda, in Healthy Subjects After Intravenous Administration.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Assess the pharmacodynamic profile of the drug test in comparison to the comparator through the measurement of the activity of the Anti-FXa and anti-FIIa markers
研究概览
简要总结
The hypothesis of this trial is that the test drug (Enoxalow® - T) pharmacodynamics parameters are similar to the comparator drug (Clexane® - C) in healthy subjects following administration of single intravenous dose. The objective of this randomized, crossover, clinical trial is to evaluate the pharmacodynamic profile of the test drug Enoxalow® - T produced by Blau Farmacêutica, compared to the comparator drug Clexane®, produced by Sanofi-Aventis, by determining pharmacodynamic activities (including anti FXa and anti-FIIa), as surrogate markers for their circulating concentrations of the drug.
详细描述
In addition other pharmacodynamic tests such as Tissue Factor Pathway Inhibitor (TFPI) activity, as well as the ratio of anti-FXa and anti-FIIa activity will be compared as secundary obectives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Agree to all the purposes of the study by signing and dating the Informed Consent;
- •Male, aged between 18 and 55 years, clinically healthy;
- •BMI between 18.5 and 30;
排除标准
- •Participation in clinical trials in the 12 months preceding the trial;
- •Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases;
- •Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study;
- •Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug;
- •Hemoglobin <13 g/dL;
- •Continuous use of oral anticoagulants, platelet inhibitors or anti-inflammatory drugs;
- •Use of medications that interact with enoxaparin;
- •History of gastrointestinal bleeding, deep vein thrombosis or pulmonary embolism that may interfere with the clinical outcome of the study;
- •History of coagulopathy and bleeding diathesis;
- •Presence of changes in physical examination suggestive of coagulation disorders (bruising, petechiae, or bruising);
- •Body weight < 45 kg or > 100 kg;
- •Absolute platelet count below 100 x 109 / L;
- •History of chronic bleeding;
- •History of acute haemorrhage in the past 30 days;
- •History of sensitivity to mammalian-derived biological products, albumin or any component of the formulation;
- •History of allergy or Steven Johnson disease;
- •Current or previous history (under 12 months) use of illicit drugs and tobacco;
- •History of alcohol abuse, current or previous (within 12 months);
- •At the discretion of the Principal Investigator of the study.
研究组 & 干预措施
Teste
Enoxalow (Heparin, Low-Molecular-Weight) - Blau Farmacêutica S/A.
干预措施: Heparin, Low-Molecular-Weight (Drug)
Comparador
Clexane (Heparin, Low-Molecular-Weight)- Sanofi-Aventis
干预措施: Heparin, Low-Molecular-Weight (Drug)
结局指标
主要结局
Assess the pharmacodynamic profile of the drug test in comparison to the comparator through the measurement of the activity of the Anti-FXa and anti-FIIa markers
时间窗: The day after admission
Post drug administration blood samples were collected at following times - 0; 0:10; 0:20; 0:30; 00:40 12:50; 1; 1:30; two; 2:30; 3; 3:30; 4; 5; 6; 8; 10; 12; 16:24 (± 30) hours after.
次要结局
- Assess the pharmacodynamic profile of the drug test in comparison to the comparator through the measurement of the activity of the TFPI marker and ratio of Anti-FXa and anti-FIIa.(The day after admission)