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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03125187
Other study ID # PGUQ005
Secondary ID
Status Suspended
Phase Phase 1
First received
Last updated
Start date February 20, 2021
Est. completion date November 10, 2022

Study information

Verified date March 2019
Source União Química Farmacêutica Nacional S/A
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Suspended
Enrollment 24
Est. completion date November 10, 2022
Est. primary completion date February 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Sodium heparin UQ Intravenous 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 intravenous 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
Sodium heparin FK Intravenous 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 intravenous 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

Locations

Country Name City State
Brazil União Química Farmacêutica Nacional São Paulo

Sponsors (2)

Lead Sponsor Collaborator
União Química Farmacêutica Nacional S/A Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary activity of the anti-Xa factor Chromogenic determination of direct and indirect Xa inhibitors in human citrated plasma 8 hours
Secondary Activity of anti-IIa factors, Chromogenic determination of activity of anti-IIa factor 8 hours
Secondary ratio of activity of anti-Xa / anti-IIa activity of anti-Xa / anti-IIa ratio 8 hours
Secondary Activity of tissue factor pathway activity (TFPI) Elisa assay to measure the activity of tissue factor pathway activity (TFPI) 8 hours
Secondary adverse events. Adverse events occurred in the study 45 days
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