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

• ClinicalTrials.gov Identifier: NCT01651923
• Recruitment Status: Unknown
• First Posted: July 27, 2012
• Last Update Posted: August 13, 2012
• Sponsor: Azidus Brasil
• Information provided by (Responsible Party): Azidus Brasil

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Heparin	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: February 2013
• Estimated Primary Completion Date: April 2013
• Estimated Study Completion Date: April 2013

Arms and Interventions

Arm	Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :

1. 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. ]
   Blood samples

Secondary Outcome Measures :

1. 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 ]
   Blood samples

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes 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

Contacts

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

Locations

Brazil

LAL Clínica Pesquisa e Desenvolvimento Ltda.

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

Azidus Brasil

More Information

• Responsible Party: Azidus Brasil
• ClinicalTrials.gov Identifier: NCT01651923
• Other Study ID Numbers: HEPBLA0312IV-I; Versão 01 - 15/03/2012
• First Posted: July 27, 2012
• Last Update Posted: August 13, 2012
• Last Verified: August 2012

Keywords provided by Azidus Brasil:

subjects

Additional relevant MeSH terms:

Heparin; Calcium heparin; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action