Study With Heparin Sodium in Intravenous Administration

NCT ID: NCT03125187

Last Updated: 2019-10-15

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-20
• Study Completion Date: 2022-11-10

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.

Conditions

Heparin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Sodium heparin UQ Intravenous drug administration

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

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

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

Group Type: EXPERIMENTAL

Sodium heparin UQ Intravenous drug administration

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME

INDUSTRY

Sponsor Role: collaborator

União Química Farmacêutica Nacional S/A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paula F Santos

Role: STUDY_DIRECTOR

União Química Farmacêutica Nacional S/A

Locations

União Química Farmacêutica Nacional

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

PGUQ005

Identifier Type: -

Identifier Source: org_study_id