Heparin
Conditions
Keywords
Sodium Heparin, Pharmacokinetics, Coagulation factor
Brief summary
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.
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.
Interventions
BIOLOGICALSodium Heparin UQ subcutaneous drug administration
The participants will be hospitalized one day to receive the Sodium heparin UQ experimental medication or Sodium heparin FK comparator medication. They will receive the Subcutaneous medication and start the blood collection at the programmed time. After 7 days, the participants will return to receive the other medication and have their blood collected. The last visit will be to collect safety datas
BIOLOGICALSodium Heparin FK subcutaneous drug administration
The participants will be hospitalized one day to receive the Sodium heparin FK comparator medication or Sodium heparin UQ experimental medication. They will receive the subcutaneous medication and start the blood collection at the programmed time. After 7 days, the participants will return to receive the other medication and have their blood collected. The last visit will be to collect safety datas
Sponsors
Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME
União Química Farmacêutica Nacional S/A
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Hospitalizations for 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Activity of the anti-Xa factor | 8 hours | Chromogenic determination of direct and indirect inhibitors in human citrated plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | 45 days | Adverse events occurred in the study |
| activity of anti-Xa / anti-IIa ratio | 8 hours | the calculated ratio of the activity of anti-Xa / anti-IIa |
| activity of tissue factor pathway activity (TFPI) | 8 hours | the Elisa assay will determine the activity of tissue factor pathway activity (TFPI) |
| Activity of anti-IIa factor | 8 hours | Chromogenic determination of direct and indirect inhibitors in human citrated plasma |
Countries
Brazil
Outcome results
None listed