Trials / Unknown
UnknownNCT05788900
Evaluation of the Pharmacodynamics of a Heparin With Its Biological Comparator, Intravenous Administration
Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacodynamics of an Unfractionated Heparin Compared to Heparin Sodium Injection, USP (Comparator) After Intravenous 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
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Heparin | intravenous 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
Source: ClinicalTrials.gov record NCT05788900. Inclusion in this directory is not an endorsement.