PHARMACODYNAMICS ASSESSMENT PRODUCT HEPARIN SODIUM (INTRAVENOUSLY) OF THE SWINE 5.000UI/ML OF BLAU FARMACÊUTICA S/A IN HEALTHY SUBJECTS IN COMPARISON OF SODIUM HEPARIN APP PHARMACEUTICALS

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01651923
First received: July 25, 2012
Last updated: August 10, 2012
Last verified: August 2012
  Purpose

The objective of this clinical, randomized, crossover, is to assess the pharmacodynamic profile of the drug Heparin Sodium from swine (intravenously), manufactured and marketed by Laboratory Blau Farmacêutica S/A, compared to the product of Heparin Sodium ® company APP Pharmaceuticals, through the determination of activity of the following markers:

  • Anti-FXa;
  • Anti-FIIA.

Condition Intervention Phase
Healthy
Drug: Heparin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Pharmacodynamic of activity of markers: Anti-Fxa and Anti-FIIA [ Time Frame: 0:20, 0:10 before administration and 0:10, 0:20, 0:30, 0:45, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30 , 5, 6, 8, 12 and 24 hours after drug administration. ] [ Designated as safety issue: Yes ]
    Blood samples


Secondary Outcome Measures:
  • Pharmacodynamic of the ratio between the activity Anti-FXa/Anti-FIIa and the activity of TFPI and TTPa [ Time Frame: TFPI: 0:20, 0:10 before administration and 0:10, 0:20, 0:30, 0:45, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30 , 5, 6, 8, 12 and 24 hours after drug administration. TTPa: 0:20, 0:10 before administration and 1 h, 4h, 8h, 12h and 24h after drug administration ] [ Designated as safety issue: Yes ]
    Blood samples


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A

First periody: Heparin Test Drug (Blau Farmacêutica S/A)

Secundy periody: Heparin Comparator Drug (APP Pharmaceuticals)

Drug: Heparin
Whereas it will be a crossover study with two periods, each drug will be administered only once, at a dose of 5.000UI. In each period, the drug will be administered intravenously.
Other Names:
  • Sodium heparin (Blau Farmacêutica S/A)
  • Sodium heparin (App Pharmaceuticals)
Group B

First periody: Heparin Comparator Drug (APP Pharmaceuticals)

Secundy periody: Heperin Test Drug (Blau Farmacêutica S/A)

Drug: Heparin
Whereas it will be a crossover study with two periods, each drug will be administered only once, at a dose of 5.000UI. In each period, the drug will be administered intravenously.
Other Names:
  • Sodium heparin (Blau Farmacêutica S/A)
  • Sodium heparin (App Pharmaceuticals)

Detailed Description:

The pharmacodynamic profile of the drug will be assessed through:

  • Reason for Anti-FXa activity / Anti-FIIA;
  • TFPI activity.

The aPTT activity marker will be evaluated as an exploratory objective.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • a) Confirm the voluntary participation and agree to all the purposes of the study by signing and dating the IC in two ways; b) Being male, aged between 18 and 55 years old and clinically healthy; c) BMI ≥ 18.5 and ≤ 30.

Exclusion Criteria:

  • a) Participation in clinical trials in the 12 months preceding the survey; b) Presence of pulmonary diseases, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems; c) acute illness in the period up to 07 days before the beginning of the study; d) determining Chronic administration of medications, such as hypertension, diabetes or any other that requires continued use of any drug; e) Hemoglobin <13 g / dL; f) Continuous use of oral anticoagulants, platelet inhibitors or anti-inflammatory; g) Use of medications that interact with heparin (see Section 7.8.1); h) history of gastrointestinal bleeding, deep vein thrombosis or pulmonary embolism; i) History of coagulopathy and bleeding diathesis; j) Presence of bruises on physical examination. k) Changes in skin or subcutaneous tissue of the place where the injection is made ​​(eg liposuction in the abdomen).

    l) absolute platelet count below 100 x 109 / L; m) A history of acute haemorrhage in the last 30 days; n) history of sensitivity to biological products derived from mammalian albumin or any component of the formulation;

    a) history of allergy or major disease Steven Johnson; p) History of present use or there are at least 12 months of tobacco; q) current or previous history (less than 12 months) of illicit drug use;

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651923

Contacts
Contact: Alexandre Frederico, physian + 55 19 3871-6399 alexandre@lalclinica.com.br

Locations
Brazil
LAL Clínica Pesquisa e Desenvolvimento Ltda. Not yet recruiting
Valinhos, São Paulo, Brazil, 13276245
Contact: Alexandre Frederico, physician    + 55 19 3871-6399    alexandre@lalclinica.com.br   
Principal Investigator: Alexandre Frederico, physician         
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier: NCT01651923     History of Changes
Other Study ID Numbers: HEPBLA0312IV-I, Versão 01 - 15/03/2012
Study First Received: July 25, 2012
Last Updated: August 10, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
subjects

Additional relevant MeSH terms:
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014