Phase I Study With Pharmacodynamic Determination of Unfractionated Heparin of Porcine Origin of the Company União Química of Subcutaneous Use in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Activity of the anti-Xa factor
研究概览
简要总结
The purpose of this phase I study is to know the pharmacodynamic profile in humans of the sodium heparin of porcine origin of the company União Química, building from the pharmacodynamic data generated its pharmacokinetic profile, due to the dosage limitation of heparin directly in biological samples. In addition, the toxicity of the product will be evaluated in healthy male participants.
详细描述
This stage of product development follows the guidelines of the ANVISA (National Health Surveillance Agency) Heparin Development Guide.
Unfractionated sodium heparin is a drug known and widely used in the world for over half a century, thus, no unknown adverse events or any risk of administration are expected in humans, however, this is the first human Biological product developed by União Química. The proposed development of this biological drug follows the individual route, the control heparin used in the present study has the objective of evaluating the results found with the test product, without the obligation to demonstrate bioequivalence among the evaluated products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Eligible healthy participants should sign the Informed Consent Form,
- •be between 18 and 60 years of age,
- •present a BMI ≥ 18.5 and ≤ 29.9 kg / m2,
- •be characterized as a voluntary (Normal physical examination)
- •no history of current or recent diseases.
- •Exclusion criteria:
- •hemoglobin <12 g / dL;
- •Platelets <100 x 109 / L;
- •Regular or last 30 days use of anticoagulant medications;
- •Current or past use of anti-inflammatory or anti-platelet medications;
- •History of gastrointestinal bleeding;
- •History of venous thrombosis, pulmonary embolism, coagulopathies or any coagulation disorder;
- •Any other chronic illness or regular use of drugs that at the discretion of the investigator contraindicates participation in the study,
- •serious comorbidity (at the discretion of the researcher) of any nature that could compromise participation in the study or put the participant at risk considered to be unacceptable,
- •Laboratory that at the discretion of the investigator contraindicates the participation of the participant in the study;
- •Hypersensitivity or contraindication to the components of the medications studied, participation in another clinical study in less than 1 year (unless justified by the investigator)
- •donation of blood (> 500 mL) in the preceding 3 months.
排除标准
- 未提供
研究组 & 干预措施
Group Sodium Heparin UQ First
The participants will receive the Sodium heparin UQ subcutaneous drug administration at first period and the Sodium heparin FK subcutaneous drug administration at second period
干预措施: Sodium Heparin UQ subcutaneous drug administration (Biological)
Group Sodium Heparin UQ First
The participants will receive the Sodium heparin UQ subcutaneous drug administration at first period and the Sodium heparin FK subcutaneous drug administration at second period
干预措施: Sodium Heparin FK subcutaneous drug administration (Biological)
Group Sodium Heparin FK First
The participants will receive the Sodium heparin FK subcutaneous drug administration at first period and the Sodium heparin UQ subcutaneous drug administration at second period
干预措施: Sodium Heparin UQ subcutaneous drug administration (Biological)
Group Sodium Heparin FK First
The participants will receive the Sodium heparin FK subcutaneous drug administration at first period and the Sodium heparin UQ subcutaneous drug administration at second period
干预措施: Sodium Heparin FK subcutaneous drug administration (Biological)
结局指标
主要结局
Activity of the anti-Xa factor
时间窗: 8 hours
Chromogenic determination of direct and indirect inhibitors in human citrated plasma
次要结局
- adverse events(45 days)
- Activity of anti-IIa factor(8 hours)
- activity of tissue factor pathway activity (TFPI)(8 hours)
- activity of anti-Xa / anti-IIa ratio(8 hours)