Ignite Creation Date:
2024-05-05 @ 10:18 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01074593
Status:
COMPLETED
Last Update Posted:
2013-02-25
First Post:
2009-11-13
Brief Title:
Pharmacokinetics and Pharmacodynamics of the Interferon Beta-1a Produced by Laboratorio Quimico Farmaceutico Bergamo Compared to Interferon Beta-1a Rebif - Merck Serono in Healthy Subjects
Sponsor:
Azidus Brasil
Organization:
Azidus Brasil
Study Overview
Official Title:
Clinical Study of Pharmacokinetics and Pharmacodynamics of the Drug Interferon Beta-1a Produced By Laboratorio Quimico Farmaceutico Bergamo Compared To Interferon Beta-1a Rebif - Merck Serono In Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2013-02
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 this study is to compare the pharmacokinetic and pharmacodynamic effect of two commercial preparations of interferon beta-1a IFN Test Lab Bergamo and IFN Comparator Rebif - Merck Serono Lab after single administration 12000UI in healthy subjects by modifying the parameters Cmax Tmax and AUC pharmacokinetics and the levels of 25 oligoadenylate synthase and beta-2-microglobulin pharmacodynamics
Detailed Description:
Secondly safety will be observed tolerability clinically after administration of a single dose in study subjects by comparing the clinical and laboratory parameters before and after study and the incidence of adverse events
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 |
|---|---|---|---|
| VERSION 3 | None | None | None |