Viewing Study NCT01074593



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