Study With Heparin Sodium in Intravenous Administration

October 11, 2019 updated by: União Química Farmacêutica Nacional S/A

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

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • São Paulo, Brazil
        • União Química Farmacêutica Nacional

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sodium heparin UQ First
The participants will receive the Sodium heparin UQ intravenous drug administration at first period and the Sodium heparin FK intravenous drug administration at second period
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
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
Experimental: Sodium Heparin FK First
The participants will receive the Sodium heparin FK intravenous drug administration at first period and the Sodium heparin UQ intravenous drug administration at second period
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
activity of the anti-Xa factor
Time Frame: 8 hours
Chromogenic determination of direct and indirect Xa inhibitors in human citrated plasma
8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity of anti-IIa factors,
Time Frame: 8 hours
Chromogenic determination of activity of anti-IIa factor
8 hours
ratio of activity of anti-Xa / anti-IIa
Time Frame: 8 hours
activity of anti-Xa / anti-IIa ratio
8 hours
Activity of tissue factor pathway activity (TFPI)
Time Frame: 8 hours
Elisa assay to measure the activity of tissue factor pathway activity (TFPI)
8 hours
adverse events.
Time Frame: 45 days
Adverse events occurred in the study
45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 20, 2021

Primary Completion (Anticipated)

February 20, 2021

Study Completion (Anticipated)

November 10, 2022

Study Registration Dates

First Submitted

March 29, 2017

First Submitted That Met QC Criteria

April 18, 2017

First Posted (Actual)

April 24, 2017

Study Record Updates

Last Update Posted (Actual)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 11, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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