Ignite Creation Date:
2024-05-06 @ 3:14 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02246842
Status:
COMPLETED
Last Update Posted:
2018-03-14
First Post:
2014-09-15
Brief Title:
A Study Comparing the Pharmacokinetics and Tolerance of D-Gam to Rhophylac in Rh-D-negative Healthy Volunteers
Sponsor:
Bio Products Laboratory
Organization:
Bio Products Laboratory
Study Overview
Official Title:
A Randomised Study Comparing the Pharmacokinetics and Tolerance of D-Gam 1500IU to Rhophylac 1500IUin Rh-D-negative Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2018-03
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:
The primary objective of the study was to compare peak serum anti-D levels Cmax of BPLs D-Gam 1500 IU to Rhophylac 1500IU in RhD-negative healthy volunteers
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