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

NCT05788913 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-03-29

No results posted yet for this study

Summary

Experimental Drug: Porcine sodium heparin, injectable solution - 5,000 IU/ 0.25 mL; Blau Farmacêutica S/A.

Comparator Drug: Heparin Sodium Injection, USP, injectable solution - 5,000 IU/ 0.5 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

Interventions

BIOLOGICAL

Heparin

subcutaneous Heparin

Sponsors & Collaborators

  • Blau Farmaceutica S.A.

    lead INDUSTRY

Principal Investigators

  • Clinical Research · Blau Farmaceutica S.A.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2023-06-30
Completion
2023-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05788913 on ClinicalTrials.gov