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

July 25, 2012
August 10, 2012
February 2013
April 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01651923 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
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
Not Provided

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
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 A

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

    Secundy periody: Heparin Comparator Drug (APP Pharmaceuticals)

    Intervention: Drug: Heparin
  • Group B

    First periody: Heparin Comparator Drug (APP Pharmaceuticals)

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

    Intervention: Drug: Heparin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
April 2013
April 2013   (final data collection date for primary outcome measure)

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;

Male
18 Years to 55 Years
Yes
Contact: Alexandre Frederico, physian + 55 19 3871-6399 alexandre@lalclinica.com.br
Brazil
 
NCT01651923
HEPBLA0312IV-I, Versão 01 - 15/03/2012
Not Provided
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Not Provided
Not Provided
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP