Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-27 @ 4:15 AM
Study NCT ID:
NCT01685359
Status:
COMPLETED
Last Update Posted:
2022-10-28
First Post:
2012-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PK and PD Parallel Study After Multiple Dose, Intravenous Administration of Two Epoetin Alfa, Human Recombinant
Sponsor:
Azidus Brasil
Organization:
Study Overview
Official Title:
Phase 1 Assessment of Pharmacokinetics and Pharmacodynamics of Two Epoetin Alfa, Human Recombinant Epoetin (Blau Farmacêutica) and Eprex (Janssen-Cilag), After Multiple Dose, Intravenous Administration in Healthy Subjects: a Randomized Parallel Study.
Status:
COMPLETED
Status Verified Date:
2022-10
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:
None
Brief Summary:
The hypothesis of this trial is that the test drug (Human Recombiant Epoetin - Blau) pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ® - Janssen-Cilag) in healthy subjects following administration of multiple intravenous dose. The objective of this randomized, parallel, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of the test drug Human Reconbiant Epoetin produced by Blau Farmacêutica, compared to the comparator drug Eprex®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count following a multiple intravenous administration during 4 weeks of 100 IU/kg in healthy subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Version 1 25/06/2012 | OTHER | LAL Clinica | View |