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Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Filgrastim (G-CSF)Produced by Blausiegel Indústria e Comércio Ltda. Compared to Granulokine Produced by Produtos Roche Químicos e Farmacêuticos S/A.

This study is not yet open for participant recruitment.
Verified March 2012 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Sponsor:
Information provided by (Responsible Party):
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01549301
First received: March 6, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  Purpose

The primary aim of this study is to compare the pharmacokinetic and pharmacodynamic effects of two commercial preparations of filgrastim (T and C), after single dose via subcutaneous or intravenous administration at a concentration of 5 mcg/kg or 10 mcg/kg in healthy subjects through the alteration in the pharmacokinetic and pharmacodynamic parameters (measurement of serum levels of G-CSF and absolute neutrophil count - ANC).


Condition Intervention Phase
Healthy Subjects
 Drug: Filgrastim
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • The primary efficacy parameters will be based on the investigation of pharmacokinetics and pharmacodynamics of filgrastim in research subjects after administration of single dose via sc or iv routes at doses of 5 or 10 mcg/kg of the drug. [ Time Frame: • PK.: 0, 15 min., 30 min., 45 min., 1h, 1h e 30min., 2h, 3h, 4h, 6h, 8h,10h, 12h, 16h, 24h and 48h. • PD (ANC): 0, 30 min., 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 32h, 48h, 72h, 96h and 120h ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 128
Study Start Date: August 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group D 10 i.v.
Two periods, crossover, single dose, i.v., 10 mcg, Comparator (n=16) x Test (n=16) in the first period and Test (n=16) x Comparator (n=16) in the second period, in a crossover basis.
 Drug: Filgrastim
Filgrastim, i.v., single dose, dosage: 10 mcg/kg
Experimental: Group C 5 i.v.
Two periods, crossover, single dose, i.v., 5 mcg, Comparator (n=16) x Test (n=16) in the first period and Test (n=16) x Comparator (n=16) in the second period, in a crossover basis.
 Drug: Filgrastim
Filgrastim, i.v., single dose, dosage: 5 mcg/kg
Experimental: Group B 10 s.c.
Two periods, crossover, single dose, s.c., 10 mcg/kg, Comparator (n=16) x Test (n=16) in the first period and Test (n=16) x Comparator (n=16) in the second period, in a crossover basis.
 Drug: Filgrastim
filgrastim, single dose, s.c., dosage: 10 mcg/kg
Experimental: Group A 5 s.c.
Two periods, crossover, single dose, s.c., 5 mcg, Comparator (n=16) x Test (n=16) in the first period and Test (n=16) x Comparator (n=16) in the second period, in a crossover basis.
 Drug: Filgrastim
filgrastim, single dose, s.c., dosage: 5 mcg/kg

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Agree with all study procedures, sign and date back by their own free will, the IC;
  • Be between 18 and 50 years, of both sexes;
  • Present a body mass index (BMI) greater than or equal to 20 and less than or equal to 28;
  • are considered healthy, clinical, psychological and laboratory;
  • are female, but they have and maintain a safe method of contraception during the study.

Exclusion Criteria:

  • Known hypersensitivity to filgrastim;
  • Hypersensitivity to products derived from E. coli;
  • fever or infectious disease in the 07 days preceding the first administration;
  • Positive serology for hepatitis B or C and HIV;
  • Prior treatment with CSFs, interleukins and interferons;
  • Participation in a clinical study in the last 12 months;
  • Donation or loss of blood in the 03 months preceding the study;
  • General anesthesia in the 03 months preceding the study;
  • Provide a history of alcohol abuse, drug or drugs;
  • Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological, psoriasis, gout, acute myocardial infarction, thyroid or psychiatric disease;
  • Pregnant or lactating women.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549301

Contacts
Contact: Alexandre Frederico, Dr (55) 19 38716399 alexandre@lalclinica.com.br

Locations
Brazil
LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, Sao Paulo, Brazil
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier: NCT01549301     History of Changes
Other Study ID Numbers: FILBLA1211I, Version 01 - 09/12/2011
Study First Received: March 6, 2012
Last Updated: March 6, 2012
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013