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

Phase 1

• Conditions: Healthy
• Interventions: Drug: Heparin

• Registration Number: NCT01652638
• Lead Sponsor: Azidus Brasil

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.

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 Timeline

• Study First Submitted: 2012-07-26
• Study First Submitted QC: 2012-07-27
• Study First Posted: 2012-07-30
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-10
• Last Update Posted: 2012-08-13
• Study Start: 2013-02
• Primary Completion: 2013-04
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pharmacodynamic of activity of markers: Anti-Fxa and Anti-FIIA.	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 sample

Secondary Outcome Measures

Name	Time	Method
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.	Blood sample

Trial Locations

Locations (1)

LAL Clínica Pesquisa e Desenvolvimento Ltda.; 🇧🇷 Valinhos, Brazil