Ignite Creation Date:
2024-05-06 @ 7:20 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02517788
Status:
COMPLETED
Last Update Posted:
2015-08-10
First Post:
2015-08-05
Brief Title:
Phase I BP Interferon IFN Beta-004
Sponsor:
Centre Hospitalier Universitaire Vaudois
Organization:
Centre Hospitalier Universitaire Vaudois
Study Overview
Official Title:
Comparative Pharmacokinetic Profile of Interferon Beta-1a Bioferon Administered as Single iv Doses in HSA-free Formulation and HSA Solution and as Multiple sc Doses in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2015-08
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:
Phase I study aiming at
establishing the pharmacokinetic profile of interferon beta-1a after iv administration of the formulation BioPartners IFN beta-1a without albumin HSA-free solution in pre-filled syringes at 18 MIU
investigating the possible impact of albumin on pharmacokinetic profile by comparing 3 different iv formulations BioPartners IFN beta-1a without albumin HSA-free solution in pre-filled syringes BioPartners IFN beta-1a with added albumin HSA and Rebif from Merck-Serono a registered IFN beta-1a solution containing HSA
establishing the steady state pharmacokinetic profile of BioPartners IFN beta-1a in HSA-free solution after 4 subsequent sc doses of 18 MIU given at 48 hour intervals against Rebif using the same regimen
establishing the pharmacokinetic profile of interferon beta-1a after iv administration of the formulation BioPartners IFN beta-1a without albumin HSA-free solution in pre-filled syringes at 18 MIU
investigating the possible impact of albumin on pharmacokinetic profile by comparing 3 different iv formulations BioPartners IFN beta-1a without albumin HSA-free solution in pre-filled syringes BioPartners IFN beta-1a with added albumin HSA and Rebif from Merck-Serono a registered IFN beta-1a solution containing HSA
establishing the steady state pharmacokinetic profile of BioPartners IFN beta-1a in HSA-free solution after 4 subsequent sc doses of 18 MIU given at 48 hour intervals against Rebif using the same regimen
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006DR1162 | REGISTRY | Swissmedic | None |