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

NCT01652638 | Unknown Phase 1

• 2 other identifiers: HEPBLA0312SC-IVersion 01 15/03/2012
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

subjects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  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.

Study Arms (2)

Group A

EXPERIMENTAL

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

Drug: Heparin

Group B

EXPERIMENTAL

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

Drug: Heparin

Interventions

Heparin DRUG

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)

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

LAL Clínica Pesquisa e Desenvolvimento Ltda.

Valinhos, Valinhos, 13276245, Brazil

Location

MeSH Terms

Interventions

Heparin

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Alexandre Frederico, physician

CONTACT

+55 19 3871-6399; alexandre@lalclinica.com.br

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: July 30, 2012
• Study Start: February 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 13, 2012

Record last verified: 2012-08

Locations

BR (1)