Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
Study NCT ID:
NCT05788900
Status:
UNKNOWN
Last Update Posted:
2023-03-29
First Post:
2023-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Pharmacodynamics of a Heparin With Its Biological Comparator, Intravenous Administration
Sponsor:
Blau Farmaceutica S.A.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: