- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03125187
Study With Heparin Sodium in Intravenous Administration
October 11, 2019 updated by: União Química Farmacêutica Nacional S/A
Phase I Study With Pharmacodynamic Determination of Unfractionated Heparin of Porcine Origin of the Company União Química of Intravenous Use in Healthy Participants
The purpose of this phase I study is to know the pharmacodynamic profile in in intravenous application in humans of the sodium heparin of porcine origin of the company União Química, building from the pharmacodynamic data generated its pharmacokinetic profile, due to the dosage limitation of heparin directly in biological samples.
In addition, the toxicity of the product will be evaluated in healthy male participants.
Study Overview
Status
Suspended
Conditions
Detailed Description
This stage of product development follows the guidelines of the ANVISA (National Health Surveillance Agency) Heparin Development Guide.
Unfractionated sodium heparin is a drug known and widely used in the world for over half a century, thus, no unknown adverse events or any risk of administration are expected in humans, however, this is the first human Biological product developed by União Química.
The proposed development of this biological drug follows the individual route, the control heparin used in the present study has the objective of evaluating the results found with the test product, without the obligation to demonstrate bioequivalence among the evaluated products.
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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São Paulo, Brazil
- União Química Farmacêutica Nacional
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Eligible healthy participants should sign the Informed Consent Form,
- be between 18 and 60 years of age,
- be male,
- present a BMI ≥ 18.5 and ≤ 29.9 kg / m2,
- be characterized as a voluntary (Normal physical examination)
- no history of current or recent diseases.
Exclusion Criteria:
- hemoglobin <12 g / dL;
- Platelets <100 x 109 / L;
- Regular or last 30 days use of anticoagulant medications;
- Current or past use of anti-inflammatory or anti-platelet medications;
- History of gastrointestinal bleeding;
- History of venous thrombosis, pulmonary embolism, coagulopathies or any coagulation disorder;
- Any other chronic illness or regular use of drugs that at the discretion of the investigator contraindicates participation in the study,
- serious comorbidity (at the discretion of the researcher) of any nature that could compromise participation in the study or put the participant at risk considered to be unacceptable,
- Laboratory that at the discretion of the investigator contraindicates the participation of the participant in the study;
- Hypersensitivity or contraindication to the components of the medications studied, participation in another clinical study in less than 1 year (unless justified by the investigator)
- donation of blood (> 500 mL) in the preceding 3 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sodium heparin UQ First
The participants will receive the Sodium heparin UQ intravenous drug administration at first period and the Sodium heparin FK intravenous drug administration at second period
|
The participants will be hospitalized one day to receive the Sodium heparin UQ experimental medication or Sodium heparin FK comparator medication.
They will receive the intravenous medication and start the blood collection at the programmed time.
After 7 days, the participants will return to receive the other medication and have their blood collected.
The last visit will be to collect safety datas
The participants will be hospitalized one day to receive the Sodium heparin FK comparator medication or Sodium heparin UQ experimental medication.
They will receive the intravenous medication and start the blood collection at the programmed time.
After 7 days, the participants will return to receive the other medication and have their blood collected.
The last visit will be to collect safety datas
|
Experimental: Sodium Heparin FK First
The participants will receive the Sodium heparin FK intravenous drug administration at first period and the Sodium heparin UQ intravenous drug administration at second period
|
The participants will be hospitalized one day to receive the Sodium heparin UQ experimental medication or Sodium heparin FK comparator medication.
They will receive the intravenous medication and start the blood collection at the programmed time.
After 7 days, the participants will return to receive the other medication and have their blood collected.
The last visit will be to collect safety datas
The participants will be hospitalized one day to receive the Sodium heparin FK comparator medication or Sodium heparin UQ experimental medication.
They will receive the intravenous medication and start the blood collection at the programmed time.
After 7 days, the participants will return to receive the other medication and have their blood collected.
The last visit will be to collect safety datas
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
activity of the anti-Xa factor
Time Frame: 8 hours
|
Chromogenic determination of direct and indirect Xa inhibitors in human citrated plasma
|
8 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activity of anti-IIa factors,
Time Frame: 8 hours
|
Chromogenic determination of activity of anti-IIa factor
|
8 hours
|
ratio of activity of anti-Xa / anti-IIa
Time Frame: 8 hours
|
activity of anti-Xa / anti-IIa ratio
|
8 hours
|
Activity of tissue factor pathway activity (TFPI)
Time Frame: 8 hours
|
Elisa assay to measure the activity of tissue factor pathway activity (TFPI)
|
8 hours
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adverse events.
Time Frame: 45 days
|
Adverse events occurred in the study
|
45 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Paula F Santos, União Química Farmacêutica Nacional S/A
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 20, 2021
Primary Completion (Anticipated)
February 20, 2021
Study Completion (Anticipated)
November 10, 2022
Study Registration Dates
First Submitted
March 29, 2017
First Submitted That Met QC Criteria
April 18, 2017
First Posted (Actual)
April 24, 2017
Study Record Updates
Last Update Posted (Actual)
October 15, 2019
Last Update Submitted That Met QC Criteria
October 11, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PGUQ005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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