Study With Heparin Sodium in Intravenous Administration

NCT03125187 | Suspended Phase 1 DMC FDA Drug

• 1 other identifier: PGUQ005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Heparin

Keywords

Sodium Heparin; Intravenous administration; Pharmacokinetics; Coagulation factor

Outcome Measures

Primary Outcomes (1)

• activity of the anti-Xa factor

  Chromogenic determination of direct and indirect Xa inhibitors in human citrated plasma

  8 hours

Secondary Outcomes (4)

• Activity of anti-IIa factors,

  8 hours

• ratio of activity of anti-Xa / anti-IIa

  8 hours

• Activity of tissue factor pathway activity (TFPI)

  8 hours

• adverse events.

  45 days

Study Arms (2)

Sodium heparin UQ First

EXPERIMENTAL

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

Biological: Sodium heparin UQ Intravenous drug administration; Biological: Sodium heparin FK Intravenous drug administration

Sodium Heparin FK First

EXPERIMENTAL

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

Biological: Sodium heparin UQ Intravenous drug administration; Biological: Sodium heparin FK Intravenous drug administration

Interventions

Sodium heparin UQ Intravenous drug administration 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 First; Sodium heparin UQ First

Sodium heparin FK Intravenous drug administration 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; Sodium heparin UQ First

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: It is known that male participants are preferable in clinical trials due to the hormonal stability presented by males compared to females, and the results that the drug under test can present are clearer, that is, with less hormonal interference.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

União Química Farmacêutica Nacional

São Paulo, Brazil

Location

Study Officials

• Paula F Santos

  União Química Farmacêutica Nacional S/A

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Hospitalizations for intravenous 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

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 24, 2017
• Study Start: February 20, 2021
• Primary Completion: February 20, 2021
• Study Completion: November 10, 2022
• Last Updated: October 15, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)