Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-01-03 @ 8:35 PM
Study NCT ID:
NCT01664195
Status:
UNKNOWN
Last Update Posted:
2012-08-14
First Post:
2012-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PK and PD Study After Single Dose, Intravenous Administration of Two Epoetin Alfa, Eritromax and Eprex, in Healthy Subjects
Sponsor:
Azidus Brasil
Organization:
Study Overview
Official Title:
Phase 1 Assessment of Pharmacokinetics and Pharmacodynamics of Two Epoetin Alfa, Eritromax (Blau Farmacêutica) and Eprex (Janssen-Cilag), After Single Dose, Intravenous Administration in Healthy Subjects: a Randomized Study.
Status:
UNKNOWN
Status Verified Date:
2012-08
Last Known Status:
NOT_YET_RECRUITING
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 (Eritromax ®) pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects following administration of single intravenous dose. The objective of this randomized, crossover, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of the drug Eritromax® marketed by Blau Farmacêutica, compared to the product Eprex ®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count following a single-dose intravenous administration 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 01/03/2012 | OTHER | LAL Clinica | View |