HealthyPhase 1NCT01651923
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
A Phase 1 study testing Heparin in people with Healthy, run by Azidus Brasil at 1 site in Brazil.
Trial 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… 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2013to Apr 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
- 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.
Who cannot join
- 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).
- 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;
- 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 locations and contacts
1 site in 1 country.
Brazil1 site
LAL Clínica Pesquisa e Desenvolvimento Ltda.
Valinhos, São Paulo, 13276245
Alexandre Frederico, physician, + 55 19 3871-6399, alexandre@lalclinica.com.br
Alexandre Frederico, physician
About this study
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.
Read the 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
- Being tested
- Heparin
- Keywords
- subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
Also called Sodium heparin (Blau Farmacêutica S/A), Sodium heparin (App Pharmaceuticals)
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 intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | First periody: Heparin Test Drug (Blau Farmacêutica S/A)
Secundy periody: Heparin Comparator Drug (APP Pharmaceuticals) Receives: Drug: Heparin |
| Group B | Other | First periody: Heparin Comparator Drug (APP Pharmaceuticals)
Secundy periody: Heperin Test Drug (Blau Farmacêutica S/A) Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic of activity of markers: Anti-Fxa and Anti-FIIA
Blood samples
Measured: 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.
Secondary outcomes (1)
Pharmacodynamic of the ratio between the activity Anti-FXa/Anti-FIIa and the activity of TFPI and TTPa
Blood samples
Measured: 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. TTPa: 0:20, 0:10 before administration and 1 h, 4h, 8h, 12h 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 posted27 Jul 2012 (estimated)
- Study startFeb 2013
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651923
- Sponsor's protocol ID
- HEPBLA0312IV-I
- Other IDs
- Versão 01 - 15/03/2012
- Status last verified
- Aug 2012
- First submitted
- 25 Jul 2012
- Last updated
- 13 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01651923
- Acronym / sponsor ID
- HEPBLA0312IV-I
- Conditions
- Healthy
- Keywords
- subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 27 Jul 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Drug: HeparinFirst periody: Heparin Test Drug (Blau Farmacêutica S/A) Secundy periody: Heparin Comparator Drug (APP Pharmaceuticals) |
| Group B | Other | Drug: HeparinFirst periody: Heparin Comparator Drug (APP Pharmaceuticals) Secundy periody: Heperin Test Drug (Blau Farmacêutica S/A) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
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 |
|---|---|---|
| HeparinAlso: Sodium heparin (Blau Farmacêutica S/A), Sodium heparin (App Pharmaceuticals)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 intravenously. | Drug | Group A, Group B |
Primary outcome
Pharmacodynamic of activity of markers: Anti-Fxa and Anti-FIIA
Time frame: 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 samples
1 secondary outcome
Pharmacodynamic of the ratio between the activity Anti-FXa/Anti-FIIa and the activity of TFPI and TTPa
Time frame: 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. TTPa: 0:20, 0:10 before administration and 1 h, 4h, 8h, 12h and 24h after drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2012.
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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.
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 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Aug 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Frederico, physian (+ 55 19 3871-6399, alexandre@lalclinica.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamic of activity of markers: Anti-Fxa and Anti-FIIA (time frame: 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.). 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 13 Aug 2012.