Study With Heparin Sodium in Intravenous Administration
- Conditions
- Heparin
- Interventions
- Biological: Sodium heparin UQ Intravenous drug administrationBiological: Sodium heparin FK Intravenous drug administration
- Registration Number
- NCT03125187
- Lead Sponsor
- União Química Farmacêutica Nacional S/A
- Brief Summary
The purpose of this phase I study is to know the pharmacodynamic profile in in intravenous application 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- Male
- Target Recruitment
- 24
- Eligible healthy participants should sign the Informed Consent Form,
- be between 18 and 60 years of age,
- be male,
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sodium heparin UQ First Sodium heparin FK Intravenous drug administration The participants will receive the Sodium heparin UQ intravenous drug administration at first period and the Sodium heparin FK intravenous drug administration at second period Sodium Heparin FK First Sodium heparin UQ Intravenous drug administration The participants will receive the Sodium heparin FK intravenous drug administration at first period and the Sodium heparin UQ intravenous drug administration at second period Sodium Heparin FK First Sodium heparin FK Intravenous drug administration The participants will receive the Sodium heparin FK intravenous drug administration at first period and the Sodium heparin UQ intravenous drug administration at second period Sodium heparin UQ First Sodium heparin UQ Intravenous drug administration The participants will receive the Sodium heparin UQ intravenous drug administration at first period and the Sodium heparin FK intravenous drug administration at second period
- Primary Outcome Measures
Name Time Method activity of the anti-Xa factor 8 hours Chromogenic determination of direct and indirect Xa inhibitors in human citrated plasma
- Secondary Outcome Measures
Name Time Method Activity of anti-IIa factors, 8 hours Chromogenic determination of activity of anti-IIa factor
ratio of activity of anti-Xa / anti-IIa 8 hours activity of anti-Xa / anti-IIa ratio
adverse events. 45 days Adverse events occurred in the study
Activity of tissue factor pathway activity (TFPI) 8 hours Elisa assay to measure the activity of tissue factor pathway activity (TFPI)
Trial Locations
- Locations (1)
União Química Farmacêutica Nacional
🇧🇷São Paulo, Brazil