Study With Heparin Sodium in Subcutaneous Administration

Sponsor

União Química Farmacêutica Nacional S/A (Industry)

Overall Status

Suspended

CT.gov ID

NCT03113084

Collaborator

Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME (Industry)

Enrollment

Location

Arms

13.7

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heparin	Biological: Sodium Heparin UQ subcutaneous drug administration Biological: Sodium Heparin FK subcutaneous drug administration	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Phase I Study With Pharmacodynamic Determination of Unfractionated Heparin of Porcine Origin of the Company União Química of Subcutaneous Use in Healthy Participants

Anticipated Study Start Date :

Aug 20, 2022

Anticipated Primary Completion Date :

Apr 20, 2023

Anticipated Study Completion Date :

Oct 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group Sodium Heparin UQ First 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	Biological: Sodium 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 Biological: Sodium 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
Experimental: Group Sodium Heparin FK First 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	Biological: Sodium 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 Biological: Sodium 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

Arm

Intervention/Treatment

Experimental: Group Sodium Heparin UQ First

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

Biological: Sodium 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

Biological: Sodium 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

Experimental: Group Sodium Heparin FK First

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

Biological: Sodium Heparin UQ subcutaneous drug administration

Biological: Sodium Heparin FK subcutaneous drug administration

Outcome Measures

Primary Outcome Measures

Activity of the anti-Xa factor [8 hours]
Chromogenic determination of direct and indirect inhibitors in human citrated plasma

Secondary Outcome Measures

Activity of anti-IIa factor [8 hours]
Chromogenic determination of direct and indirect inhibitors in human citrated plasma
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)
adverse events [45 days]
Adverse events occurred in the study

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Male

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	União Química Farmacêutica Nacional	São Paulo		Brazil

Sponsors and Collaborators

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

Investigators

Study Director: Paula F Santos, União Química Farmacêutica Nacional S/A

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

União Química Farmacêutica Nacional S/A

ClinicalTrials.gov Identifier:

NCT03113084

Other Study ID Numbers:

PGUQ003

First Posted:

Apr 13, 2017

Last Update Posted:

Oct 14, 2019

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by União Química Farmacêutica Nacional S/A

Sodium Heparin

Pharmacokinetics

Coagulation factor

Additional relevant MeSH terms:

Heparin

Calcium heparin

Study Results

No Results Posted as of Oct 14, 2019