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

Azidus

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: Heparin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01651923

Versão 01 - 15/03/2012

HEPBLA0312IV-I

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group A

Other group

Description:

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

Treatment:

Drug: Heparin

Group B

Other group

Description:

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

Treatment:

Drug: Heparin