Completed
Pharmacodynamics Study of Enoxalow, Produced by Blau Farmacêutica S/A, Compared to Clexane, Produced by Sanofi-Aventis Farmacêutica Ltda, in Healthy Subjects After Intravenous Administration.
What is being tested
Heparin, Low-Molecular-Weight
+ Heparin, Low-Molecular-Weight
Drug
Who is being recruted
From 18 to 55 Years
+22 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: February 2013
Summary
Principal SponsorAzidus Brasil
Last updated: October 31, 2022
Sourced from a government-validated database.Claim as a partner
Study start date: February 28, 2013
Actual date on which the first participant was enrolled.In addition other pharmacodynamic tests such as Tissue Factor Pathway Inhibitor (TFPI) activity, as well as the ratio of anti-FXa and anti-FIIa activity will be compared as secundary obectives.
Principal SponsorAzidus Brasil
Last updated: October 31, 2022
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Male
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
3 inclusion criteria required to participate
Agree to all the purposes of the study by signing and dating the Informed Consent
BMI between 18.5 and 30
Male, aged between 18 and 55 years, clinically healthy
19 exclusion criteria prevent from participating
Absolute platelet count below 100 x 109 / L
Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study
At the discretion of the Principal Investigator of the study
Body weight < 45 kg or > 100 kg
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalEnoxalow (Heparin, Low-Molecular-Weight) - Blau Farmacêutica S/A.
Group II
Active ComparatorClexane (Heparin, Low-Molecular-Weight)- Sanofi-Aventis
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center