Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00493220
Status:
COMPLETED
Last Update Posted:
2011-12-02
First Post:
2007-06-26
Brief Title:
Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration
Sponsor:
Baxter Healthcare Corporation
Organization:
Baxter Healthcare Corporation
Study Overview
Official Title:
INcreased Flow Utilizing Subcutaneously-Enabled Ceftriaxone INFUSE-Ceftriaxone Study A Phase I Study Comparing the Safety and Pharmacokinetics of Ceftriaxone Administered Subcutaneously With and Without Human Recombinant Hyaluronidase HYLENEX Recombinant and Intravenously in Human Volunteers
Status:
COMPLETED
Status Verified Date:
2011-10
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:
INFUSE-Cftrx
Brief Summary:
The objectives of this study are
to establish the safety of subcutaneous administration of ceftriaxone at different concentrations with and without HYLENEX recombinant and to determine the maximum tolerated concentration
and to establish the pharmacokinetic comparability of subcutaneous administration of ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX recombinant and to IV administration
to establish the safety of subcutaneous administration of ceftriaxone at different concentrations with and without HYLENEX recombinant and to determine the maximum tolerated concentration
and to establish the pharmacokinetic comparability of subcutaneous administration of ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX recombinant and to IV administration
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None