Clinical trial NCT03125187: Study With Heparin Sodium in Intravenous Administration
Official title: Phase I Study With Pharmacodynamic Determination of Unfractionated Heparin of Porcine Origin of the Company União Química of Intravenous Use in Healthy Participants
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Heparin
Keywords: Sodium Heparin
Intravenous administration
Pharmacokinetics
Coagulation factor
Lead sponsor: União Química Farmacêutica Nacional S/A
Sponsor class: INDUSTRY
Collaborators: name: Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME
First posted: 2017-04-24
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Hospitalizations for intravenous administration of study medications will occur in two periods (visits 1 and 2) for administration of the drugs, and participants who receive the test medication at visit 1 will receive the comparator medication at Visit 2 and vice versa
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: activity of the anti-Xa factor
timeFrame: 8 hours
Secondary outcomes:
measure: Activity of anti-IIa factors,
timeFrame: 8 hours
measure: ratio of activity of anti-Xa / anti-IIa
timeFrame: 8 hours
measure: Activity of tissue factor pathway activity (TFPI)
timeFrame: 8 hours
measure: adverse events.
timeFrame: 45 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: União Química Farmacêutica Nacional
Study officials:
affiliation: União Química Farmacêutica Nacional S/A
name: Paula F Santos
role: STUDY_DIRECTOR
References: