NCT05788913

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

Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacodynamics of an Unfractionated Heparin Compared to Heparin Sodium Injection, USP (Comparator) After Subcutaneous Administration in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Blau Farmaceutica S.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
BIOLOGICAL	Heparin	subcutaneous Heparin

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-06-30
• Completion: 2023-09-30
• First posted: 2023-03-29
• Last updated: 2023-03-29