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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: Heparin

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 Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Alexandre Frederico, physician; Phone Number: +55 19 3871-6399; Email: alexandre@lalclinica.com.br

Study Locations

• Brazil
  • Valinhos, Brazil, 13276245
    • LAL Clínica Pesquisa e Desenvolvimento Ltda.
    • Contact: Alexandre Frederico, physician; Phone Number: +55 19 3871-6399; Email: alexandre@lalclinica.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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:

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; First periody: Test Drug (Heparin Blau Farmacêutica S/A) Secundy periody: Comparator Drug (Heparin 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 subcutaneously.; Other Names: Hepamax-S = Sodium heparin (Blau Farmacêutica S/A); APP Sodium heparin = Sodium heparin (App Pharmaceuticals)
Experimental: Group B; First periody: Comparator Drug (Heparin APP Pharmaceuticals) Secundy periody: Test Drug (heparin 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 subcutaneously.; Other Names: Hepamax-S = Sodium heparin (Blau Farmacêutica S/A); APP Sodium heparin = Sodium heparin (App Pharmaceuticals)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamic of activity of markers: Anti-Fxa and Anti-FIIA.	Blood sample	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamic of the ratio between the activity Anti-FXa/Anti-FIIa and the activity of TFPI.	Blood sample	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.

Collaborators and Investigators

• Sponsor: Azidus Brasil

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): April 1, 2013
• Study Completion (Anticipated): April 1, 2013

Study Registration Dates

• First Submitted: July 26, 2012
• First Submitted That Met QC Criteria: July 27, 2012
• First Posted (Estimate): July 30, 2012

Study Record Updates

• Last Update Posted (Estimate): August 13, 2012
• Last Update Submitted That Met QC Criteria: August 10, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: subjects
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: HEPBLA0312SC-I; Version 01 15/03/2012