Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05788900
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-29
First Post:
2023-01-27
Brief Title:
Evaluation of the Pharmacodynamics of a Heparin With Its Biological Comparator Intravenous Administration
Sponsor:
Blau Farmaceutica SA
Organization:
Blau Farmaceutica SA
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:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
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 - 5000 IUmL Blau Farmacêutica SA
Comparator Drug Heparin Sodium Injection USP injectable solution - 5000 IUmL 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 - 5000 IUmL Blau Farmacêutica SA
Comparator Drug Heparin Sodium Injection USP injectable solution - 5000 IUmL 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?:
None