PHARMACODYNAMICS ASSESSMENT PRODUCT HEPARIN SODIUM (SUBCUTANEOUSLY) OF THE SWINE 5.000UI/ML OF BLAU FARMACÊUTICA S/A IN HEALTHY SUBJECTS IN COMPARISON OF SODIUM HEPARIN APP PHARMACEUTICALS
试验速览
- 阶段
- 1 期
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Pharmacodynamic of activity of markers: Anti-Fxa and Anti-FIIA.
研究概览
简要总结
The objective of this clinical, randomized, crossover, is to assess the pharmacodynamic profile of the drug Heparin Sodium from swine (intravenously), manufactured and marketed by Laboratory Blau Farmacêutica S/A, compared to the product of Heparin Sodium ® company APP Pharmaceuticals, through the determination of activity of the following markers:
- Anti-FXa;
- Anti-FIIA.
详细描述
The pharmacodynamic profile of the drug will be assessed through:
- Reason for Anti-FXa activity / Anti-FIIA;
- TFPI activity.
The aPTT activity marker will be evaluated as an exploratory objective.
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
- •Confirm the voluntary participation and agree to all the purposes of the study by signing and dating the IC in two ways;
- •Being male, aged between 18 and 55 years old and clinically healthy;
- •BMI ≥ 18.5 and ≤ 30.
排除标准
- •Participation in clinical trials in the 12 months preceding the survey;
- •Presence of pulmonary diseases, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems;
- •acute illness in the period up to 07 days before the beginning of the study;
- •determining Chronic administration of medications, such as hypertension, diabetes or any other that requires continued use of any drug;
- •Hemoglobin <13 g / dL;
- •Continuous use of oral anticoagulants, platelet inhibitors or anti-inflammatory;
- •Use of medications that interact with heparin (see Section 7.8.1);
- •history of gastrointestinal bleeding, deep vein thrombosis or pulmonary embolism;
- •History of coagulopathy and bleeding diathesis;
- •Presence of bruises on physical examination.
- •Changes in skin or subcutaneous tissue of the place where the injection is made (eg liposuction in the abdomen).
- •absolute platelet count below 100 x 109 / L;
- •A history of acute haemorrhage in the last 30 days;
- •history of sensitivity to biological products derived from mammalian albumin or any component of the formulation;
- •a) history of allergy or major disease Steven Johnson; p) History of present use or there are at least 12 months of tobacco; q) current or previous history (less than 12 months) of illicit drug use;
研究组 & 干预措施
Group A
First periody: Test Drug (Heparin Blau Farmacêutica S/A)
Secundy periody: Comparator Drug (Heparin APP Pharmaceuticals)
干预措施: Heparin (Drug)
Group B
First periody: Comparator Drug (Heparin APP Pharmaceuticals)
Secundy periody: Test Drug (heparin Blau Farmacêutica S/A)
干预措施: Heparin (Drug)
结局指标
主要结局
Pharmacodynamic of activity of markers: Anti-Fxa and Anti-FIIA.
时间窗: 0:20, 0:10 before administration and 0:10, 0:20, 0:30, 0:45, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30 , 5, 6, 8, 12 and 24 hours after drug administration.
Blood sample
次要结局
- Pharmacodynamic of the ratio between the activity Anti-FXa/Anti-FIIa and the activity of TFPI.(TFPI: 0:20, 0:10 before administration and 0:10, 0:20, 0:30, 0:45, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30 , 5, 6, 8, 12 and 24 hours after drug administration.)