Study With Heparin Sodium in Subcutaneous Administration

União Química Farmacêutica Nacional

Status and phase: Suspended; Phase 1

Conditions: Heparin

Treatments: Biological: Sodium Heparin UQ subcutaneous drug administration; Biological: Sodium Heparin FK subcutaneous drug administration

Study type: Interventional

Funder types: Industry

Identifiers

NCT03113084

PGUQ003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Group Sodium Heparin UQ First

Experimental group

Description:

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

Treatment:

Biological: Sodium Heparin UQ subcutaneous drug administration

Biological: Sodium Heparin FK subcutaneous drug administration

Group Sodium Heparin FK First

Experimental group

Description:

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

Treatment:

Biological: Sodium Heparin UQ subcutaneous drug administration

Biological: Sodium Heparin FK subcutaneous drug administration