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Study With Heparin Sodium in Subcutaneous Administration

NCT03113084 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2019-10-14

No results posted yet for this study

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.

Conditions

  • Heparin

Interventions

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

Sponsors & Collaborators

  • Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME

    collaborator INDUSTRY

  • União Química Farmacêutica Nacional S/A

    lead INDUSTRY

Principal Investigators

  • Paula F Santos · União Química Farmacêutica Nacional S/A

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-20
Primary Completion
2023-04-20
Completion
2023-10-10
FDA Drug
Yes

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03113084 on ClinicalTrials.gov