HealthyPhase 1NCT01692158
Pharmacodynamics Study of Enoxalow Compared to Clexane in Healthy Subjects After Subcutaneous Single Dose
A Phase 1 study testing Heparin, Low-Molecular-Weight in people with Healthy, run by Azidus Brasil at 1 site in Brazil.
Trial summary
The hypothesis of this trial is that the test drug (Enoxalow® - T) pharmacodynamics parameters are similar to the comparator drug (Clexane® - C) in healthy subjects following administration of single subcutaneous dose. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Heparin, Low-Molecular-Weight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2013to Nov 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Agree to all the purposes of the study by signing and dating the Informed Consent;
- Male, aged between 18 and 55 years, clinically healthy;
- BMI between 18.5 and 30;
Who cannot join
- Participation in clinical trials in the 12 months preceding the trial;
- Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases;
- Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study;
- Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug;
- Hemoglobin < 13 g/dL;
- Continuous use of oral anticoagulants, platelet inhibitors or anti-inflammatory drugs;
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- Use of medications that interact with enoxaparin;
- History of gastrointestinal bleeding, deep vein thrombosis or pulmonary embolism that may interfere with the clinical outcome of the study;
- History of coagulopathy and bleeding diathesis;
- Presence of changes in physical examination suggestive of coagulation disorders (bruising, petechiae, or bruising);
- Changes in the skin or subcutaneous tissue of the place of drug administration(eg liposuction in the abdomen);
- Absolute platelet count below 100 x 109 / L;
- History of chronic bleeding;
- History of acute haemorrhage in the past 30 days;
- History of sensitivity to mammalian-derived biological products, albumin or any component of the formulation;
- History of allergy or Steven Johnson disease;
- Current or previous history (under 12 months) use of illicit drugs and tobacco;
- History of alcohol abuse, current or previous (within 12 months);
- At the discretion of the Principal Investigator of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacodynamics Study of Enoxalow, Produced by Blau Farmacêutica S/A, Compared to Clexane, Produced by Sanofi-Aventis Farmacêutica Ltda, in Healthy Subjects After Subcutaneous Administration.
The hypothesis of this trial is that the test drug (Enoxalow® - T) pharmacodynamics parameters are similar to the comparator drug (Clexane® - C) in healthy subjects following administration of single subcutaneous dose. The objective of this randomized, crossover, clinical trial is to evaluate the pharmacodynamic profile of the test drug Enoxalow® - T produced by Blau Farmacêutica, compared to the comparator drug Clexane®, produced by Sanofi-Aventis, by determining pharmacodynamic activities (including anti FXa and anti-FIIa), as surrogate markers for their circulating concentrations of the drug.
Read the detailed description
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 secondary objectives.
- Conditions
- Healthy
- Being tested
- Heparin, Low-Molecular-Weight
- Keywords
- subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin, Low-Molecular-WeightDrug
Also called Clexane, Enoxalow
single subcutaneuous administration of 40 mg of the test drug and the comparator drug, according to randomization, in a crossover design, each administration separated by 6 days of washout.
| Study group | Role | What they receive |
|---|---|---|
| Teste | Experimental | Enoxalow (Heparin, Low-Molecular-Weight) - Blau Farmacêutica S/A. Receives: Drug: Heparin, Low-Molecular-Weight |
| Comparador | Active comparator | Clexane (Heparin, Low-Molecular-Weight)- Sanofi-Aventis Receives: Drug: Heparin, Low-Molecular-Weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-FXa
Measured: 0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24h after drug administration
anti-FIIa activity
Measured: 0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24 hours after drug administration
Secondary outcomes (2)
Tissue Factor Pathway Inhibitor (TFPI)
Measured: 0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24 hours after drug administration
ratio of anti-FXa and anti-FIIa activity
Measured: 0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24h after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startMar 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandre Frederico, Principal investigator, Azidus Brasil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692158
- Sponsor's protocol ID
- ENOBLA0512SC-I
- Other IDs
- Versão 01 datada de 15.05.2012
- Status last verified
- Oct 2022
- First submitted
- 20 Sep 2012
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamics Study of Enoxalow, Produced by Blau Farmacêutica S/A, Compared to Clexane, Produced by Sanofi-Aventis Farmacêutica Ltda, in Healthy Subjects After Subcutaneous Administration.
- ClinicalTrials.gov ID
- NCT01692158
- Acronym / sponsor ID
- ENOBLA0512SC-I
- Conditions
- Healthy
- Keywords
- subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Mar 2013 (actual)
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this trial is that the test drug (Enoxalow® - T) pharmacodynamics parameters are similar to the comparator drug (Clexane® - C) in healthy subjects following administration of single subcutaneous dose. The objective of this randomized, crossover, clinical trial is to evaluate the pharmacodynamic profile of the test drug Enoxalow® - T produced by Blau Farmacêutica, compared to the comparator drug Clexane®, produced by Sanofi-Aventis, by determining pharmacodynamic activities (including anti FXa and anti-FIIa), as surrogate markers for their circulating concentrations of the drug.
Detailed description
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 secondary objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teste | Experimental | Drug: Heparin, Low-Molecular-WeightEnoxalow (Heparin, Low-Molecular-Weight) - Blau Farmacêutica S/A. |
| Comparador | Active comparator | Drug: Heparin, Low-Molecular-WeightClexane (Heparin, Low-Molecular-Weight)- Sanofi-Aventis |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Agree to all the purposes of the study by signing and dating the Informed Consent;
- Male, aged between 18 and 55 years, clinically healthy;
- BMI between 18.5 and 30;
Key exclusion criteria (19 listed)
- Participation in clinical trials in the 12 months preceding the trial;
- Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases;
- Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study;
- Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug;
- Hemoglobin < 13 g/dL;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparin, Low-Molecular-WeightAlso: Clexane, Enoxalowsingle subcutaneuous administration of 40 mg of the test drug and the comparator drug, according to randomization, in a crossover design, each administration separated by 6 days of washout. | Drug | Comparador, Teste |
Primary outcome
anti-FXa
Time frame: 0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24h after drug administration
anti-FIIa activity
Time frame: 0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24 hours after drug administration
2 secondary outcomes
Tissue Factor Pathway Inhibitor (TFPI)
Time frame: 0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24 hours after drug administration
ratio of anti-FXa and anti-FIIa activity
Time frame: 0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24h after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Frederico principal investigator
Azidus Brasil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Heparin, Low-Molecular-Weight in people with Healthy, run by Azidus Brasil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anti-FXa (time frame: 0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24h after drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.