Evaluation of the Pharmacodynamics of a Heparin With Its Biological Comparator, Intravenous Administration

NCT05788900 | Unknown Phase 1

• 1 other identifier: CAEP 98.001.22
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pharmacodynamic Study - Phase I Experimental Drug: Porcine sodium heparin, injectable solution - 5,000 IU/mL; Blau Farmacêutica S/A. Comparator Drug: Heparin Sodium Injection, USP, injectable solution - 5,000 IU/mL; Fresenius Kabi Lake Zurich. Evaluate the equivalence in terms of pharmacodynamics of heparin sodium (test product) and Heparin Sodium Injection, USP (comparator product). The clinical trial will last approximately 08 weeks and the study population will consist of 68 healthy research participants, 34 women and 34 men.

Conditions

Anticoagulant

Outcome Measures

Primary Outcomes (5)

• Evaluation of Amax parameter pharmacodynamics for the anti-FXA marker

  Amax: Maximum response, understood as the highest concentration, detected in plasma after treatment. The conclusion by the average equivalence is achieved when the confidence intervals 90% of the ratio of geometric averages of experimental and comparator drugs are between 80% and 125%.

  12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.

• Evaluation of ASCE0-t parameter pharmacodynamics for the anti-FXA marker

  ASCE0-T: area under the effect-based effect curve versus time from zero to the last experimentally determined concentration; The conclusion by the average equivalence is achieved when the confidence intervals 90% of the ratio of geometric averages of experimental and comparator drugs are between 80% and 125%

  12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.

• Evaluation of ASCE0-inf parameter pharmacodynamics for the anti-FXA marker

  ASCE0-inf: Area under the effect curve based on concentration versus time from zero to infinity experimentally determined. The conclusion by the average equivalence is achieved when the confidence intervals 90% of the ratio of geometric averages of experimental and comparator drugs are between 80% and 125%.

  12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.

• Evaluation of Amax parameter pharmacodynamics for the anti-FIIA marker

  Amax: Maximum response, understood as the highest concentration, detected in plasma after treatment. The conclusion by the average equivalence is achieved when the confidence intervals 90% of the ratio of geometric averages of experimental and comparator drugs are between 80% and 125%.

  12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.

• Evaluation of ASCE0-t parameter pharmacodynamics for the anti-FIIA marker

  ASCE0-T: area under the effect-based effect curve versus time from zero to the last experimentally determined concentration; The conclusion by the average equivalence is achieved when the confidence intervals 90% of the ratio of geometric averages of experimental and comparator drugs are between 80% and 125%.

  12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.

Secondary Outcomes (7)

• Sequence effects of pharmacodynamic parameters for the Anti-FXa marker - Analysis of variance (ANOVA)

  12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.

• Sequence effects of pharmacodynamic parameters for the Anti-FIIa marker - Analysis of variance (ANOVA)

  12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.

• Ratio of Anti-FXa/Anti-FIIa activity based on the pharmacodynamic parameter ASCE0-t

  12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.

• Occurrence of adverse events and serious eventsevents

  2 months

• Evaluation of Amax parameter pharmacodynamics for the tissue factor pathway inhibitor (TFPI) activity

  12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.

Study Arms (2)

Reference Drug

ACTIVE COMPARATOR

Healthy participants using intravenous Heparin Sodium Injection, USP (Fresenius Kabi) to assess the pharmacodynamic profile

Biological: Heparin

Test Drug

EXPERIMENTAL

Healthy participants using intravenous Heparin Test to assess the pharmacodynamic profile

Biological: Heparin

Interventions

Heparin BIOLOGICAL

intravenous Heparin

Reference Drug; Test Drug

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provide written informed consent approved by a Research Ethics Committee (CEP) prior to any trial-related activities;
• Healthy male or female participants between 18 and 55 years of age;
• Be in good health or have no significant illness at the discretion of the responsible researcher/physician, in accordance with what is defined in this protocol and the assessments to which he/she is submitted during recruitment and selection, such as: clinical history, vital signs, anthropometric data, physical examination , ECG and laboratory tests;
• Have a body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2, inclusive;
• Present body weight between 60 and 100 Kg;
• Agree to abstain from alcohol consumption for the duration of the study;
• Present a negative result for the test for detecting alcohol in urine or saliva;
• Test negative for the coronavirus (SARS-CoV-2);
• Be able to understand the nature and purpose of the study, including risks and adverse events;
• Act in accordance with the requirements of the entire trial, which is confirmed by signing the Free and Informed Consent Form (TCLE);
• The drug can bring serious risks to the fetus, so the research participant, whether female or male, must agree to use a safe contraceptive method. Male participants must refrain from donating sperm from admission to final visit\*

You may not qualify if:

• Present flu-like symptoms that, at the physician's discretion, are suspected of being infected by the coronavirus within 7 days prior to the period of hospitalization;
• Having had direct and significant contact at medical discretion with people who tested positive for the coronavirus (SARS-CoV-2) test within 14 days prior to the hospitalization period;
• Known to have a hypersensitivity reaction to the studied drug, pork foods or chemically related compounds;
• Have used regular medication within 14 days prior to the hospitalization period;
• Have used any medication within 7 days prior to the hospitalization period, except for contraceptives, cases in which, based on the half-life of the drug and/or active metabolites, complete elimination can be assumed or that, at the discretion of the responsible investigator/physician does not interfere in the pharmacokinetics or in the analytical stage of the study drug;
• Having received any vaccine dose within 7 days prior to the hospitalization period;
• Have received, within the three months prior to the study, treatment with any drug known to have well-defined toxic potential in large organs;
• Have participated in any experimental study or ingested any experimental drug within the six months prior to the start of this study;
• Have been hospitalized for any reason up to eight weeks before the start of the first treatment period of this study;
• Have a history of liver, gastrointestinal or other conditions that may interfere with the absorption, distribution, metabolism or excretion of the drug;
• Have a history of renal, respiratory, hematological, cardiological, neurological, neoplastic or psychiatric disease considered clinically significant at the physician's discretion;
• Have a history of cardiac surgery (whatever), renal (renal exeresis or agenesis), gastrointestinal (partial or total removal of the esophagus, stomach, duodenum, jejunum, ileum, ascending colon, transverse colon, descending colon, sigmoid and rectum ) and surgery of the liver or pancreas;
• Have any current symptom or disease, acute or chronic, being monitored or treated, significant at the discretion of the responsible researcher/physician;
• Possess any active systemic or immunological disease or condition, including but not limited to the following general categories: cardiovascular/pulmonary, hepatic, renal or systemic infection or lactation;
• Electrocardiographic findings not recommended at the physician's discretion for participation in the study;

Sponsors & Collaborators

• Blau Farmaceutica S.A.: lead

MeSH Terms

Interventions

Heparin

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Clinical Research

  Blau Farmaceutica S.A.

  STUDY DIRECTOR

Central Study Contacts

Blau Farmacêutica

CONTACT

114615-9400; pesquisaclinica@blau.com

Research Operations

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: March 29, 2023
• Study Start: June 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03