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

NCT ID: NCT01652638

Last Updated: 2012-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-04-30

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.

Conditions

Healthy

Keywords

subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

First periody: Test Drug (Heparin Blau Farmacêutica S/A)

Secundy periody: Comparator Drug (Heparin APP Pharmaceuticals)

Group Type: EXPERIMENTAL

Heparin

Intervention Type: 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.

Group B

First periody: Comparator Drug (Heparin APP Pharmaceuticals)

Secundy periody: Test Drug (heparin Blau Farmacêutica S/A)

Group Type: EXPERIMENTAL

Heparin

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Hepamax-S = Sodium heparin (Blau Farmacêutica S/A); APP Sodium heparin = Sodium heparin (App Pharmaceuticals)

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

LAL Clínica Pesquisa e Desenvolvimento Ltda.

Valinhos, Valinhos, Brazil

Countries

Brazil

Central Contacts

Alexandre Frederico, physician

Role: CONTACT

Phone: +55 19 3871-6399

Email: alexandre@lalclinica.com.br

Facility Contacts

Alexandre Frederico, physician

Role: primary

Other Identifiers

Version 01 15/03/2012

Identifier Type: -

Identifier Source: secondary_id

HEPBLA0312SC-I

Identifier Type: -

Identifier Source: org_study_id