Ignite Creation Date:
2024-05-06 @ 7:43 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02589301
Status:
COMPLETED
Last Update Posted:
2017-02-07
First Post:
2015-10-20
Brief Title:
Pharmacokinetics and Pharmacodynamics Comparison Study Between Two Pegfilgrastim Formulations
Sponsor:
Eurofarma Laboratorios SA
Organization:
Eurofarma Laboratorios SA
Study Overview
Official Title:
A Single-center Open-label Parallel Study With Single Subcutaneous Injection for Pharmacokinetics and Pharmacodynamics Comparison of Two Pegfilgrastim Formulations in Both Male and Female Healthy Volunteers Test Formulation is an Injectable Solution Containing 6 mg of Pegfilgrastim Manufactured by Eurofarma Laboratórios SA and Reference Formulation Neulastim Injectable Solution Containing 6 mg Marketed by Produtos Roche Químicos e Farmacêuticos SA
Status:
COMPLETED
Status Verified Date:
2016-11
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:
This study will evaluate the pharmacokinetics relative bioavailability and pharmacodynamics after single subcutaneous application in healthy volunteers of both sexes between pegfilgrastim formulation produced by Eurofarma Laboratorios SA and Neulastim reference formulation marketed by Produtos Roche Químicos e Farmacêuticos SA
In addition to that a pharmacodynamics comparison will be performed through change in absolute neutrophil count in leukogram performed in the same time of pharmacokinetics analysis collection and through CD34 cell count in peripheral blood at timepoints 000 9600 and 38400 hours
In addition to that a pharmacodynamics comparison will be performed through change in absolute neutrophil count in leukogram performed in the same time of pharmacokinetics analysis collection and through CD34 cell count in peripheral blood at timepoints 000 9600 and 38400 hours
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