CClinicalTrials.gg
Status unknownNCT01652638Updated Aug 13, 2012

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

A Phase 1 interventional study of Heparin in Healthy, sponsored by Azidus Brasil. Status unknown at 1 site in Brazil. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-13.

Sponsored by Azidus Brasil · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2012), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

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.
Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • subjects
03

In context

Lead sponsor

Azidus Brasil is the lead sponsor of 78 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Participation in clinical trials in the 12 months preceding the survey;
  2. Presence of pulmonary diseases, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems;
  3. acute illness in the period up to 07 days before the beginning of the study;
  4. determining Chronic administration of medications, such as hypertension, diabetes or any other that requires continued use of any drug;
  5. Hemoglobin \<13 g / dL;
  6. Continuous use of oral anticoagulants, platelet inhibitors or anti-inflammatory;
  7. Use of medications that interact with heparin (see Section 7.8.1);
  8. history of gastrointestinal bleeding, deep vein thrombosis or pulmonary embolism;
  9. History of coagulopathy and bleeding diathesis;
  10. Presence of bruises on physical examination.
  11. Changes in skin or subcutaneous tissue of the place where the injection is made (eg liposuction in the abdomen).
  12. absolute platelet count below 100 x 109 / L;
  13. A history of acute haemorrhage in the last 30 days;
  14. 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;

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Group A

    First periody: Test Drug (Heparin Blau Farmacêutica S/A) Secundy periody: Comparator Drug (Heparin APP Pharmaceuticals)

    Drug: Heparin

  • Experimental
    Group B

    First periody: Comparator Drug (Heparin APP Pharmaceuticals) Secundy periody: Test Drug (heparin Blau Farmacêutica S/A)

    Drug: Heparin

Interventions

  • DrugHeparin

    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 subcutaneously.

    Also known as: Hepamax-S = Sodium heparin (Blau Farmacêutica S/A), APP Sodium heparin = Sodium heparin (App Pharmaceuticals)

06

What researchers measure

Primary outcomes

  1. Pharmacodynamic of activity of markers: Anti-Fxa and Anti-FIIA.

    Blood sample

    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.

Secondary outcomes

  1. Pharmacodynamic of the ratio between the activity Anti-FXa/Anti-FIIa and the activity of TFPI.

    Blood sample

    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.

07

Study locations

1 site
  • LAL Clínica Pesquisa e Desenvolvimento Ltda.
    Valinhos, 13276245, Brazil
    • Alexandre Frederico, physician · Contact · alexandre@lalclinica.com.br · +55 19 3871-6399
    • Alexandre Frederico, physician · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01652638
Lead sponsor
Azidus Brasil
Responsible party
Sponsor
First posted
Jul 30, 2012
Start date
Feb 2013
Primary completion
Apr 2013 (estimated)
Completion
Apr 2013 (estimated)
Last update
Aug 13, 2012

Study contacts

Alexandre Frederico, physician
Contact
alexandre@lalclinica.com.br
+55 19 3871-6399
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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